Clinical Trial Results:
Immunogenicity and Safety of Sanofi Pasteur’s DTaP-IPV-HB-PRP~T Combined Vaccine Given as a Three-Dose Primary Series at 2, 3, 4 Months of Age and Followed by a Booster Dose Given at 16 to 17 Months of Age in Vietnamese Infants Who Previously Received a Dose of Hepatitis B Vaccine at Birth or within 1 Week after Birth
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Summary
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EudraCT number |
2017-004181-10 |
Trial protocol |
Outside EU/EEA |
Global end of trial date |
11 Jan 2017
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Results information
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Results version number |
v1(current) |
This version publication date |
13 May 2018
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First version publication date |
13 May 2018
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Other versions |
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Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
A3L35
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT02428491 | ||
WHO universal trial number (UTN) |
U1111-1143-8177 | ||
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Sponsors
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Sponsor organisation name |
Sanofi Pasteur
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Sponsor organisation address |
14 Espace Henry Vallée, Lyon, France, 69007
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Public contact |
Director, Clinical Development, Sanofi Pasteur, +33 (0)4 37 37 74 64, Olga.Lyabis@Sanofi.com
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Scientific contact |
Director, Clinical Development, Sanofi Pasteur, +33 (0)4 37 37 74 64, Olga.Lyabis@Sanofi.com
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
Yes
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
31 Jul 2017
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Is this the analysis of the primary completion data? |
No
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Global end of trial reached? |
Yes
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Global end of trial date |
11 Jan 2017
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
To describe the safety profile after each and all doses of Sanofi Pasteur's DTaP-IPV-HB-PRP~T in Vietnamese infants and toddlers.
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Protection of trial subjects |
All subjects that met all the study inclusion and none of the exclusion criteria, including one subject who did not meet an inclusion criterion, were randomized and vaccinated. Vaccinations were performed by qualified and trained study personnel. Subjects with allergy to any of the vaccine components were not vaccinated. After vaccination, subjects were also kept under clinical observation for 30 minutes to ensure their safety. Appropriate medical equipment were also available on site in case of any immediate allergic reactions.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
20 Apr 2015
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Vietnam: 354
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Worldwide total number of subjects |
354
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EEA total number of subjects |
0
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
354
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
0
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
Study subjects were enrolled in 1 centre in Vietnam from 20 April 2015 to 23 October 2015. | ||||||||||||||||
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Pre-assignment
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Screening details |
A total of 354 subjects who met all of the inclusion criteria and none of the exclusion criteria, including one subject who did not meet an inclusion criterion were randomized and vaccinated in this study. | ||||||||||||||||
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Period 1
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Period 1 title |
DTaP-IPV-HB-PRP~T Vaccine (overall period)
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Is this the baseline period? |
Yes | ||||||||||||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | ||||||||||||||||
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Arms
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Arm title
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DTaP-IPV-HB-PRP~T Vaccine | ||||||||||||||||
Arm description |
Subjects received 3 doses of 0.5 mL DTaP-IPV-HB-PRP~T combined vaccine, intramuscularly, at 2, 3 and 4 months of age (Infant Series), followed by a booster dose approximately 12 months after the completion of the Infant Series (at 16 to 17 months of age). | ||||||||||||||||
Arm type |
Experimental | ||||||||||||||||
Investigational medicinal product name |
DTaP-IPV-HB-PRP~T Combined Vaccine
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Investigational medicinal product code |
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Other name |
Hexaxim
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Pharmaceutical forms |
Suspension for injection in pre-filled syringe
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Routes of administration |
Intramuscular use
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Dosage and administration details |
0.5 mL, intramuscular injection into the anterolateral area of the right thigh.
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Baseline characteristics reporting groups
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Reporting group title |
DTaP-IPV-HB-PRP~T Vaccine
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Reporting group description |
Subjects received 3 doses of 0.5 mL DTaP-IPV-HB-PRP~T combined vaccine, intramuscularly, at 2, 3 and 4 months of age (Infant Series), followed by a booster dose approximately 12 months after the completion of the Infant Series (at 16 to 17 months of age). | ||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
DTaP-IPV-HB-PRP~T Vaccine
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Reporting group description |
Subjects received 3 doses of 0.5 mL DTaP-IPV-HB-PRP~T combined vaccine, intramuscularly, at 2, 3 and 4 months of age (Infant Series), followed by a booster dose approximately 12 months after the completion of the Infant Series (at 16 to 17 months of age). | ||
Subject analysis set title |
Group 3 A3L15
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Subject analysis set type |
Per protocol | ||
Subject analysis set description |
Subjects from Study A3L15 (NCT01105559 and 2011-004450-26), who had been given DTaP-IPV-HB-PRP~T vaccine at 6, 10, and 14 weeks of age following Hep B vaccination at birth, were included in this group for the non-inferiority analysis.
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End point title |
Number of Subjects Reporting Solicited Injection Site Reactions (Pain, Erythema, Swelling) After Infant Series [1] | ||||||||||||||||||
End point description |
A solicited reaction was an AE prelisted in the electronic case report from (eCRF) and considered to be related to vaccination. Injection site reactions: pain (Grade 3: Cried when injected limb was moved, or the movement of the injected limb was reduced), erythema and swelling (Grade 3: >= 50 mm). Number of subjects with any solicited injection-site reaction and Grade 3 solicited injection-site reactions were reported. Analysis was performed on safety analysis set after infant series, which included all subjects who received at least 1 dose of infant series vaccine.
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End point type |
Primary
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End point timeframe |
Within 7 days after any vaccination
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| Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As the endpoint is descriptive in nature, no statistical analysis is provided. |
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| No statistical analyses for this end point | |||||||||||||||||||
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End point title |
Number of Subjects Reporting Solicited Systemic Reactions (Pyrexia, Vomiting, Crying, Somnolence, Decreased Appetite, Irritability) After Infant Series [2] | ||||||||||||||||||||||||||||||
End point description |
A solicited reaction was an AE prelisted in eCRF and considered to be related to vaccination. Systemic reactions: pyrexia (Grade 3: >39.5 degree Celsius), vomiting (Grade 3: >= 6 episodes per 24 hours), crying (Grade 3: >3 hours), somnolence (Grade 3: Sleeping most of the time/difficult to wake up), decreased appetite (Grade 3: Refuses >=3 feeds/meals or most feeds/meals) & irritability (Grade 3: Inconsolable). Number of subjects with any systemic reaction and Grade 3 systemic reactions were reported. Analysis was performed on safety analysis set after infant series. Here, "n" signifies number of subjects with available data for each category.
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End point type |
Primary
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End point timeframe |
Within 7 days after any vaccination
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| Notes [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As the endpoint is descriptive in nature, no statistical analysis is provided. |
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| No statistical analyses for this end point | |||||||||||||||||||||||||||||||
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End point title |
Number of Subjects Reporting Solicited Injection Site Reactions (Pain, Erythema, Swelling, Extensive Swelling of Vaccinated Limb) After Booster Vaccination [3] | ||||||||||||||||||||||
End point description |
A solicited reaction was an AE prelisted in the eCRF and considered to be related to vaccination. Injection site reactions: pain (Grade 3: Cried when injected limb was moved, or the movement of the injected limb was reduced), erythema and swelling (Grade 3: >= 50 mm). Number of subjects with any solicited injection-site systemic reaction and Grade 3 solicited injection-site reactions were reported. Analysis was performed on safety analysis set after booster dose, which included all subjects who received booster vaccine.
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End point type |
Primary
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End point timeframe |
Within 7 days after vaccination
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| Notes [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As the endpoint is descriptive in nature, no statistical analysis is provided. |
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| No statistical analyses for this end point | |||||||||||||||||||||||
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End point title |
Number of Subjects Reporting Solicited Systemic Reactions (Pyrexia, Vomiting, Crying, Somnolence, Decreased Appetite, Irritability) After Booster Vaccination [4] | ||||||||||||||||||||||||||||||
End point description |
A solicited reaction is an AE prelisted in the eCRF and considered to be related to vaccination. Systemic reactions: pyrexia (Grade 3: >39.5 degree Celsius), vomiting (Grade 3: >=6 episodes per 24 hours), crying (Grade 3: >3 hours), somnolence (Grade 3: Sleeping most of the time or difficult to wake up), decreased appetite (Grade 3: Refuses>=3 feeds/meals or most feeds/meals) & irritability (Grade 3: Inconsolable). Number of subjects with any systemic reaction and Grade 3 systemic reactions were reported. Analysis was performed on safety analysis set after booster dose. Here, "n" signifies number of subjects with available data for each category.
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End point type |
Primary
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End point timeframe |
Within 7 days after vaccination
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| Notes [4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As the endpoint is descriptive in nature, no statistical analysis is provided. |
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| No statistical analyses for this end point | |||||||||||||||||||||||||||||||
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End point title |
Number of Subjects With Seroprotection/Seroconversion/Vaccine Response After Infant Series in Cohort 1 | ||||||||||||||||||||||||||||||||||||||||||||
End point description |
Seroconversion:4fold increase in anti-Pertussis(PT)& anti-Filamentous hemagglutinin(FHA) antibody(Ab) concentrations from pre-vaccination to one month after first dose.Vaccine response:anti-PT/anti-FHA Ab concentrations in Enzyme Linked Immunosorbent Assay(ELISA) units(EU)/mL>=4*Lower Limit of Quantitation(LLOQ) if pre-vaccination concentration <4*LLOQ/>=pre-vaccination concentration if pre-vaccination concentrations>=4*LLOQ. Seroprotection:anti-Diphtheria &anti-Tetanus>=0.01 International Units(IU)/mL&>=0.1 IU/mL;anti-PT &anti-FHA>=2 EU/mL &>=8 EU/mL;anti-Polyribosyl Ribitol Phosphate(PRP)>=0.15 microgram per milliliter(mcg/mL) &>=1.0mcg/mL;anti-Polio types 1,2,&3>=8(1/dilution),anti-Hepatitis B>=10 mili-international units per mililiter(mIU/mL)&>=100 mIU/mL.Analysis performed on per protocol analysis set which included subjects from Cohort 1 who received at least one dose of study vaccine & excluding those who had protocol deviations.n=subjects with available data for each category.
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End point type |
Secondary
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End point timeframe |
Day 0 (pre-vaccination, only for anti-PT and anti-FHA) and Day 90 (1 month after third dose)
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| No statistical analyses for this end point | |||||||||||||||||||||||||||||||||||||||||||||
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End point title |
Number of Subjects With Seroprotection/Seroconversion/Vaccine and Booster Response Before and After Booster Vaccination in Cohort 1 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
Seroconversion:4fold increase in anti-PT & anti-FHA Ab concentrations from pre-booster vaccination to 1 month after booster dose.Vaccine response post-booster vaccination:post-booster Ab concentrations>=4*LLOQ if pre-dose 1 Ab concentrations<4*LLOQ/post-booster Ab concentrations>=pre-dose 1 Ab concentrations if pre-dose 1>=4*LLOQ. Booster response:>=4 fold Ab concentrations increase from pre-dose 4 to one-month post-dose 4 if one-month post-dose 3<4*LLOQ/>=2 fold Ab concentrations increase from pre-dose 4 to one-month post-dose 4 if pre-dose 4>=4*LLOQ.Seroprotection:anti-Diphtheria & anti-Tetanus>=0.01 IU/mL &>=0.1 IU/mL &>=1.0 IU/mL;anti-PRP >=0.15 mcg/mL &>=1.0 mcg/mL;anti-Polio types 1, 2, & 3>=8 (1/dilution),anti-Hepatitis B>=10 mIU/mL &>=100 mIU/mL. Analysis performed on booster per-protocol analysis set which included subjects from Cohort 1 who received booster dose of study vaccine & excluding those who had protocol deviations.n=subjects with available data for each category.
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End point type |
Secondary
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End point timeframe |
Day 425 (pre-booster) and Day 455 (1 month after booster dose)
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| No statistical analyses for this end point | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End point title |
Geometric Mean Titers or Geometric Mean Concentrations of DTaP-IPV-HB-PRP~T Antibodies Before and After Infant Series in Cohort 1 | ||||||||||||||||||||||||||||||
End point description |
Anti-diphtheria Ab levels were measured by a toxin neutralization test. Anti-tetanus, anti- pertussis toxin (anti-PT) and anti- filamentous hemagglutinin (anti-FHA) Ab levels were measured by ELISA. Anti-poliovirus types 1, 2, and 3 Ab levels were measured by neutralization assay. Anti-Hep B Ab levels were measured by VITROS ECi/ECiQ Immunodiagnostic system using chemiluminescence detection technology. Anti-PRP Ab levels were measured using a Farr-type radioimmunoassay (RIA). Analysis was performed on per-protocol analysis set which included subjects from Cohort 1 who received at least one dose of study vaccine and excluding those who had protocol deviations. Here, "n" signifies number of subjects with available data for each category.
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End point type |
Secondary
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End point timeframe |
Day 0 (pre-vaccination, only for anti-PT and anti-FHA) and Day 90 (1 month after third dose)
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| No statistical analyses for this end point | |||||||||||||||||||||||||||||||
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End point title |
Geometric Mean Titers or Geometric Mean Concentrations of DTaP-IPV-HB-PRP~T Antibodies Before and After Booster Vaccination in Cohort 1 | ||||||||||||||||||||||||||||||||||||||||||||
End point description |
Anti-diphtheria Ab were measured by a toxin neutralization test. Anti-tetanus, anti-PT and anti-FHA Ab levels were measured by ELISA. Anti-poliovirus types 1, 2, and 3 Ab levels were measured by neutralization assay. Anti-Hep B Ab levels were measured by VITROS ECi/ECiQ Immunodiagnostic system using chemiluminescence detection technology. Anti-PRP Ab levels were measured using a Farr-type RIA. Analysis was performed on booster per-protocol analysis set which included subjects from Cohort 1 who received the booster dose of study vaccine and excluding those who had protocol deviations. Here, "n" signifies number of subjects with available data for each category.
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End point type |
Secondary
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End point timeframe |
Day 425 (pre-booster) and Day 455 (1 month after booster dose)
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| No statistical analyses for this end point | |||||||||||||||||||||||||||||||||||||||||||||
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End point title |
Geometric Mean Titer Ratio of DTaP-IPV-HB-PRP~T Antibodies After Infant Series in Cohort 1 for PT and FHA Antigens | ||||||||||||
End point description |
Anti-PT and anti-FHA Ab levels were measured by ELISA. Analysis was performed on per-protocol analysis set which included subjects from Cohort 1 who received at least one dose of study vaccine and excluding those who had protocol deviations.
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End point type |
Secondary
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End point timeframe |
Day 0 (pre-vaccination) and Day 90 (1 month after third dose)
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Geometric Mean Concentration/Titer Ratio of DTaP-IPV-HB-PRP~T Antibodies After Booster Vaccination in Cohort 1 | ||||||||||||||||||||||||||
End point description |
Anti-diphtheria Ab were measured by a toxin neutralization test. Anti-tetanus, anti-PT and anti-FHA Ab levels were measured by ELISA. Anti-poliovirus types 1, 2, and 3 Ab levels were measured by neutralization assay. Anti-Hep B Ab levels were measured by VITROS ECi/ECiQ Immunodiagnostic system using chemiluminescence detection technology. Anti-PRP Ab levels were measured using a Farr-type RIA. Analysis was performed on booster per-protocol analysis set which included subjects from Cohort 1 who received the booster dose of study vaccine and excluding those who had protocol deviations. Here, "n" signifies number of subjects with available data for each category.
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End point type |
Secondary
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End point timeframe |
Day 425 (pre-booster) and Day 455 (1 month after booster dose)
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| No statistical analyses for this end point | |||||||||||||||||||||||||||
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End point title |
Percentage of Subjects With Seroprotection/Seroconversion Rates after Infant Series in Cohort 1 and Group 3 of A3L15 (U1111-1111-5789, NCT ID: NCT01105559, EudraCT number: 2011-004433-14) | |||||||||||||||||||||||||||||||||||||||
End point description |
Seroconversion defined as 4-fold increase in anti-PT & anti-FHA Ab concentrations from pre-vaccination to one month after first dose. Seroprotection defined as following: anti-Diphtheria & anti-Tetanus >=0.01 IU/mL; anti-PT & anti-FHA >=4EU/mL; anti-PRP >=0.15 mcg/mL; anti-Polio types 1, 2, & 3 >=8 (1/dilution), anti-Hepatitis B >=10 mIU/mL. Analysis performed on per protocol analysis set, which included subjects from Cohort 1 who received at least one dose of study vaccine & excluding those who had protocol deviations. Here, "n" signifies number of subjects with available data for each category.
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End point type |
Secondary
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End point timeframe |
Day 90 (1 month after third dose)
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Statistical analysis title |
Non-inferiority analysis of anti-D antibodies | |||||||||||||||||||||||||||||||||||||||
Statistical analysis description |
Non-inferiority concluded if the lower limit of the two-sided 95% CI for the rates observed 30 days after the third infant series dose in A3L35 lies entirely above the reference value (rates observed 30 days after the third dose in Group 3 of A3L15) minus the clinical acceptable limit of 10%. This statistical data represents data of only DTaP-IPV-HB-PRP~T combined vaccine group (number of subject analyzed= 163).
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Comparison groups |
DTaP-IPV-HB-PRP~T Vaccine v Group 3 A3L15
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Number of subjects included in analysis |
290
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Analysis specification |
Pre-specified
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Analysis type |
non-inferiority | |||||||||||||||||||||||||||||||||||||||
Method |
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Parameter type |
percentage of subjects | |||||||||||||||||||||||||||||||||||||||
Point estimate |
99.4
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Confidence interval |
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level |
95% | |||||||||||||||||||||||||||||||||||||||
sides |
2-sided
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lower limit |
96.6 | |||||||||||||||||||||||||||||||||||||||
upper limit |
100 | |||||||||||||||||||||||||||||||||||||||
Statistical analysis title |
Non-inferiority analysis of anti-T antibodies | |||||||||||||||||||||||||||||||||||||||
Statistical analysis description |
Non-inferiority concluded if the lower limit of the two-sided 95% CI for the rates observed 30 days after the third infant series dose in A3L35 lies entirely above the reference value (rates observed 30 days after the third dose in Group 3 of A3L15) minus the clinical acceptable limit of 10%. This statistical data represents data of only DTaP-IPV-HB-PRP~T combined vaccine group (number of subject analyzed= 166).
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Comparison groups |
DTaP-IPV-HB-PRP~T Vaccine v Group 3 A3L15
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Number of subjects included in analysis |
290
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Analysis specification |
Pre-specified
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Analysis type |
non-inferiority | |||||||||||||||||||||||||||||||||||||||
Method |
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Parameter type |
percentage of subjects | |||||||||||||||||||||||||||||||||||||||
Point estimate |
100
|
|||||||||||||||||||||||||||||||||||||||
Confidence interval |
||||||||||||||||||||||||||||||||||||||||
level |
95% | |||||||||||||||||||||||||||||||||||||||
sides |
2-sided
|
|||||||||||||||||||||||||||||||||||||||
lower limit |
97.8 | |||||||||||||||||||||||||||||||||||||||
upper limit |
100 | |||||||||||||||||||||||||||||||||||||||
Statistical analysis title |
Non-inferiority analysis of anti-PRP antibodies | |||||||||||||||||||||||||||||||||||||||
Statistical analysis description |
Non-inferiority concluded if the lower limit of the two-sided 95% CI for the rates observed 30 days after the third infant series dose in A3L35 lies entirely above the reference value (rates observed 30 days after the third dose in Group 3 of A3L15) minus the clinical acceptable limit of 10%. This statistical data represents data of only DTaP-IPV-HB-PRP~T combined vaccine group (number of subject analyzed= 166).
|
|||||||||||||||||||||||||||||||||||||||
Comparison groups |
DTaP-IPV-HB-PRP~T Vaccine v Group 3 A3L15
|
|||||||||||||||||||||||||||||||||||||||
Number of subjects included in analysis |
290
|
|||||||||||||||||||||||||||||||||||||||
Analysis specification |
Pre-specified
|
|||||||||||||||||||||||||||||||||||||||
Analysis type |
non-inferiority | |||||||||||||||||||||||||||||||||||||||
Method |
||||||||||||||||||||||||||||||||||||||||
Parameter type |
percentage of subjects | |||||||||||||||||||||||||||||||||||||||
Point estimate |
94.6
|
|||||||||||||||||||||||||||||||||||||||
Confidence interval |
||||||||||||||||||||||||||||||||||||||||
level |
95% | |||||||||||||||||||||||||||||||||||||||
sides |
2-sided
|
|||||||||||||||||||||||||||||||||||||||
lower limit |
90 | |||||||||||||||||||||||||||||||||||||||
upper limit |
97.5 | |||||||||||||||||||||||||||||||||||||||
Statistical analysis title |
Non-inferiority analysis of anti-PRP antibodies | |||||||||||||||||||||||||||||||||||||||
Statistical analysis description |
Non-inferiority concluded if the lower limit of the two-sided 95% CI for the rates observed 30 days after the third infant series dose in A3L35 lies entirely above the reference value (rates observed 30 days after the third dose in Group 3 of A3L15) minus the clinical acceptable limit of 10%. This statistical data represents data of only DTaP-IPV-HB-PRP~T combined vaccine group (number of subject analyzed= 166).
|
|||||||||||||||||||||||||||||||||||||||
Comparison groups |
DTaP-IPV-HB-PRP~T Vaccine v Group 3 A3L15
|
|||||||||||||||||||||||||||||||||||||||
Number of subjects included in analysis |
290
|
|||||||||||||||||||||||||||||||||||||||
Analysis specification |
Pre-specified
|
|||||||||||||||||||||||||||||||||||||||
Analysis type |
non-inferiority | |||||||||||||||||||||||||||||||||||||||
Method |
||||||||||||||||||||||||||||||||||||||||
Parameter type |
percentage of subjects | |||||||||||||||||||||||||||||||||||||||
Point estimate |
94.6
|
|||||||||||||||||||||||||||||||||||||||
Confidence interval |
||||||||||||||||||||||||||||||||||||||||
level |
95% | |||||||||||||||||||||||||||||||||||||||
sides |
2-sided
|
|||||||||||||||||||||||||||||||||||||||
lower limit |
90 | |||||||||||||||||||||||||||||||||||||||
upper limit |
97.5 | |||||||||||||||||||||||||||||||||||||||
Statistical analysis title |
Non-inferiority analysis of anti-FHA antibodies | |||||||||||||||||||||||||||||||||||||||
Statistical analysis description |
Non-inferiority concluded if the lower limit of the two-sided 95% CI for the rates observed 30 days after the third infant series dose in A3L35 lies entirely above the reference value (rates observed 30 days after the third dose in Group 3 of A3L15) minus the clinical acceptable limit of 10%. This statistical data represents data of only DTaP-IPV-HB-PRP~T combined vaccine group (number of subject analyzed= 167).
|
|||||||||||||||||||||||||||||||||||||||
Comparison groups |
DTaP-IPV-HB-PRP~T Vaccine v Group 3 A3L15
|
|||||||||||||||||||||||||||||||||||||||
Number of subjects included in analysis |
290
|
|||||||||||||||||||||||||||||||||||||||
Analysis specification |
Pre-specified
|
|||||||||||||||||||||||||||||||||||||||
Analysis type |
non-inferiority | |||||||||||||||||||||||||||||||||||||||
Method |
||||||||||||||||||||||||||||||||||||||||
Parameter type |
percentage of subjects | |||||||||||||||||||||||||||||||||||||||
Point estimate |
96.4
|
|||||||||||||||||||||||||||||||||||||||
Confidence interval |
||||||||||||||||||||||||||||||||||||||||
level |
95% | |||||||||||||||||||||||||||||||||||||||
sides |
2-sided
|
|||||||||||||||||||||||||||||||||||||||
lower limit |
92.3 | |||||||||||||||||||||||||||||||||||||||
upper limit |
98.7 | |||||||||||||||||||||||||||||||||||||||
Statistical analysis title |
Non-inferiority analysis of antiPolio-1 antibodies | |||||||||||||||||||||||||||||||||||||||
Statistical analysis description |
Non-inferiority concluded if the lower limit of the two-sided 95% CI for the rates observed 30 days after the third infant series dose in A3L35 lies entirely above the reference value (rates observed 30 days after the third dose in Group 3 of A3L15) minus the clinical acceptable limit of 10%. This statistical data represents data of only DTaP-IPV-HB-PRP~T combined vaccine group (number of subject analyzed= 163).
|
|||||||||||||||||||||||||||||||||||||||
Comparison groups |
DTaP-IPV-HB-PRP~T Vaccine v Group 3 A3L15
|
|||||||||||||||||||||||||||||||||||||||
Number of subjects included in analysis |
290
|
|||||||||||||||||||||||||||||||||||||||
Analysis specification |
Pre-specified
|
|||||||||||||||||||||||||||||||||||||||
Analysis type |
non-inferiority | |||||||||||||||||||||||||||||||||||||||
Method |
||||||||||||||||||||||||||||||||||||||||
Parameter type |
percentage of subjects | |||||||||||||||||||||||||||||||||||||||
Point estimate |
100
|
|||||||||||||||||||||||||||||||||||||||
Confidence interval |
||||||||||||||||||||||||||||||||||||||||
level |
95% | |||||||||||||||||||||||||||||||||||||||
sides |
2-sided
|
|||||||||||||||||||||||||||||||||||||||
lower limit |
97.8 | |||||||||||||||||||||||||||||||||||||||
upper limit |
100 | |||||||||||||||||||||||||||||||||||||||
Statistical analysis title |
Non-inferiority analysis of antiPolio-2 antibodies | |||||||||||||||||||||||||||||||||||||||
Statistical analysis description |
Non-inferiority concluded if the lower limit of the two-sided 95% CI for the rates observed 30 days after the third infant series dose in A3L35 lies entirely above the reference value (rates observed 30 days after the third dose in Group 3 of A3L15) minus the clinical acceptable limit of 10%. This statistical data represents data of only DTaP-IPV-HB-PRP~T combined vaccine group (number of subject analyzed= 164).
|
|||||||||||||||||||||||||||||||||||||||
Comparison groups |
DTaP-IPV-HB-PRP~T Vaccine v Group 3 A3L15
|
|||||||||||||||||||||||||||||||||||||||
Number of subjects included in analysis |
290
|
|||||||||||||||||||||||||||||||||||||||
Analysis specification |
Pre-specified
|
|||||||||||||||||||||||||||||||||||||||
Analysis type |
non-inferiority | |||||||||||||||||||||||||||||||||||||||
Method |
||||||||||||||||||||||||||||||||||||||||
Parameter type |
percentage of subjects | |||||||||||||||||||||||||||||||||||||||
Point estimate |
100
|
|||||||||||||||||||||||||||||||||||||||
Confidence interval |
||||||||||||||||||||||||||||||||||||||||
level |
95% | |||||||||||||||||||||||||||||||||||||||
sides |
2-sided
|
|||||||||||||||||||||||||||||||||||||||
lower limit |
97.8 | |||||||||||||||||||||||||||||||||||||||
upper limit |
100 | |||||||||||||||||||||||||||||||||||||||
Statistical analysis title |
Non-inferiority analysis of antiPolio-3 antibodies | |||||||||||||||||||||||||||||||||||||||
Statistical analysis description |
Non-inferiority concluded if the lower limit of the two-sided 95% CI for the rates observed 30 days after the third infant series dose in A3L35 lies entirely above the reference value (rates observed 30 days after the third dose in Group 3 of A3L15) minus the clinical acceptable limit of 10%. This statistical data represents data of only DTaP-IPV-HB-PRP~T combined vaccine group (number of subject analyzed= 166).
|
|||||||||||||||||||||||||||||||||||||||
Comparison groups |
DTaP-IPV-HB-PRP~T Vaccine v Group 3 A3L15
|
|||||||||||||||||||||||||||||||||||||||
Number of subjects included in analysis |
290
|
|||||||||||||||||||||||||||||||||||||||
Analysis specification |
Pre-specified
|
|||||||||||||||||||||||||||||||||||||||
Analysis type |
non-inferiority | |||||||||||||||||||||||||||||||||||||||
Method |
||||||||||||||||||||||||||||||||||||||||
Parameter type |
percentage of subjects | |||||||||||||||||||||||||||||||||||||||
Point estimate |
100
|
|||||||||||||||||||||||||||||||||||||||
Confidence interval |
||||||||||||||||||||||||||||||||||||||||
level |
95% | |||||||||||||||||||||||||||||||||||||||
sides |
2-sided
|
|||||||||||||||||||||||||||||||||||||||
lower limit |
97.8 | |||||||||||||||||||||||||||||||||||||||
upper limit |
100 | |||||||||||||||||||||||||||||||||||||||
Statistical analysis title |
Non-inferiority analysis of anti-Hep B antibodies | |||||||||||||||||||||||||||||||||||||||
Statistical analysis description |
Non-inferiority concluded if the lower limit of the two-sided 95% CI for the rates observed 30 days after the third infant series dose in A3L35 lies entirely above the reference value (rates observed 30 days after the third dose in Group 3 of A3L15) minus the clinical acceptable limit of 10%. This statistical data represents data of only DTaP-IPV-HB-PRP~T combined vaccine group (number of subject analyzed= 167).
|
|||||||||||||||||||||||||||||||||||||||
Comparison groups |
DTaP-IPV-HB-PRP~T Vaccine v Group 3 A3L15
|
|||||||||||||||||||||||||||||||||||||||
Number of subjects included in analysis |
290
|
|||||||||||||||||||||||||||||||||||||||
Analysis specification |
Pre-specified
|
|||||||||||||||||||||||||||||||||||||||
Analysis type |
non-inferiority | |||||||||||||||||||||||||||||||||||||||
Method |
||||||||||||||||||||||||||||||||||||||||
Parameter type |
percentage of subjects | |||||||||||||||||||||||||||||||||||||||
Point estimate |
98.2
|
|||||||||||||||||||||||||||||||||||||||
Confidence interval |
||||||||||||||||||||||||||||||||||||||||
level |
95% | |||||||||||||||||||||||||||||||||||||||
sides |
2-sided
|
|||||||||||||||||||||||||||||||||||||||
lower limit |
94.8 | |||||||||||||||||||||||||||||||||||||||
upper limit |
99.6 | |||||||||||||||||||||||||||||||||||||||
Statistical analysis title |
Non-inferiority analysis of anti-D antibodies | |||||||||||||||||||||||||||||||||||||||
Statistical analysis description |
Non-inferiority concluded if the lower limit of the two-sided 95% CI for the rates observed 30 days after the third infant series dose in A3L35 lies entirely above the reference value (rates observed 30 days after the third dose in Group 3 of A3L15) minus the clinical acceptable limit of 10%. This statistical data represents data of only group 3 A3L15 (number of subject analyzed= 122).
|
|||||||||||||||||||||||||||||||||||||||
Comparison groups |
DTaP-IPV-HB-PRP~T Vaccine v Group 3 A3L15
|
|||||||||||||||||||||||||||||||||||||||
Number of subjects included in analysis |
290
|
|||||||||||||||||||||||||||||||||||||||
Analysis specification |
Pre-specified
|
|||||||||||||||||||||||||||||||||||||||
Analysis type |
non-inferiority | |||||||||||||||||||||||||||||||||||||||
Method |
||||||||||||||||||||||||||||||||||||||||
Parameter type |
percentage of subjects | |||||||||||||||||||||||||||||||||||||||
Point estimate |
95.1
|
|||||||||||||||||||||||||||||||||||||||
Confidence interval |
||||||||||||||||||||||||||||||||||||||||
level |
95% | |||||||||||||||||||||||||||||||||||||||
sides |
2-sided
|
|||||||||||||||||||||||||||||||||||||||
lower limit |
89.6 | |||||||||||||||||||||||||||||||||||||||
upper limit |
98.2 | |||||||||||||||||||||||||||||||||||||||
Statistical analysis title |
Non-inferiority analysis of anti-T antibodies | |||||||||||||||||||||||||||||||||||||||
Statistical analysis description |
Non-inferiority concluded if the lower limit of the two-sided 95% CI for the rates observed 30 days after the third infant series dose in A3L35 lies entirely above the reference value (rates observed 30 days after the third dose in Group 3 of A3L15) minus the clinical acceptable limit of 10%. This statistical data represents data of only group 3 A3L15 (number of subject analyzed= 122).
|
|||||||||||||||||||||||||||||||||||||||
Comparison groups |
DTaP-IPV-HB-PRP~T Vaccine v Group 3 A3L15
|
|||||||||||||||||||||||||||||||||||||||
Number of subjects included in analysis |
290
|
|||||||||||||||||||||||||||||||||||||||
Analysis specification |
Pre-specified
|
|||||||||||||||||||||||||||||||||||||||
Analysis type |
non-inferiority | |||||||||||||||||||||||||||||||||||||||
Method |
||||||||||||||||||||||||||||||||||||||||
Parameter type |
percentage of subjects | |||||||||||||||||||||||||||||||||||||||
Point estimate |
100
|
|||||||||||||||||||||||||||||||||||||||
Confidence interval |
||||||||||||||||||||||||||||||||||||||||
level |
95% | |||||||||||||||||||||||||||||||||||||||
sides |
2-sided
|
|||||||||||||||||||||||||||||||||||||||
lower limit |
97 | |||||||||||||||||||||||||||||||||||||||
upper limit |
100 | |||||||||||||||||||||||||||||||||||||||
Statistical analysis title |
Non-inferiority analysis of anti-PRP antibodies | |||||||||||||||||||||||||||||||||||||||
Statistical analysis description |
Non-inferiority concluded if the lower limit of the two-sided 95% CI for the rates observed 30 days after the third infant series dose in A3L35 lies entirely above the reference value (rates observed 30 days after the third dose in Group 3 of A3L15) minus the clinical acceptable limit of 10%. This statistical data represents data of only group 3 A3L15 (number of subject analyzed= 122).
|
|||||||||||||||||||||||||||||||||||||||
Comparison groups |
DTaP-IPV-HB-PRP~T Vaccine v Group 3 A3L15
|
|||||||||||||||||||||||||||||||||||||||
Number of subjects included in analysis |
290
|
|||||||||||||||||||||||||||||||||||||||
Analysis specification |
Pre-specified
|
|||||||||||||||||||||||||||||||||||||||
Analysis type |
non-inferiority | |||||||||||||||||||||||||||||||||||||||
Method |
||||||||||||||||||||||||||||||||||||||||
Parameter type |
percentage of subjects | |||||||||||||||||||||||||||||||||||||||
Point estimate |
97.5
|
|||||||||||||||||||||||||||||||||||||||
Confidence interval |
||||||||||||||||||||||||||||||||||||||||
level |
95% | |||||||||||||||||||||||||||||||||||||||
sides |
2-sided
|
|||||||||||||||||||||||||||||||||||||||
lower limit |
93 | |||||||||||||||||||||||||||||||||||||||
upper limit |
99.5 | |||||||||||||||||||||||||||||||||||||||
Statistical analysis title |
Non-inferiority analysis of anti-PT antibodies | |||||||||||||||||||||||||||||||||||||||
Statistical analysis description |
Non-inferiority concluded if the lower limit of the two-sided 95% CI for the rates observed 30 days after the third infant series dose in A3L35 lies entirely above the reference value (rates observed 30 days after the third dose in Group 3 of A3L15) minus the clinical acceptable limit of 10%. This statistical data represents data of only group 3 A3L15 (number of subject analyzed= 103).
|
|||||||||||||||||||||||||||||||||||||||
Comparison groups |
DTaP-IPV-HB-PRP~T Vaccine v Group 3 A3L15
|
|||||||||||||||||||||||||||||||||||||||
Number of subjects included in analysis |
290
|
|||||||||||||||||||||||||||||||||||||||
Analysis specification |
Pre-specified
|
|||||||||||||||||||||||||||||||||||||||
Analysis type |
non-inferiority | |||||||||||||||||||||||||||||||||||||||
Method |
||||||||||||||||||||||||||||||||||||||||
Parameter type |
percentage of subjects | |||||||||||||||||||||||||||||||||||||||
Point estimate |
95.1
|
|||||||||||||||||||||||||||||||||||||||
Confidence interval |
||||||||||||||||||||||||||||||||||||||||
level |
95% | |||||||||||||||||||||||||||||||||||||||
sides |
2-sided
|
|||||||||||||||||||||||||||||||||||||||
lower limit |
89 | |||||||||||||||||||||||||||||||||||||||
upper limit |
98.4 | |||||||||||||||||||||||||||||||||||||||
Statistical analysis title |
Non-inferiority analysis of anti-FHA antibodies | |||||||||||||||||||||||||||||||||||||||
Statistical analysis description |
Non-inferiority concluded if the lower limit of the two-sided 95% CI for the rates observed 30 days after the third infant series dose in A3L35 lies entirely above the reference value (rates observed 30 days after the third dose in Group 3 of A3L15) minus the clinical acceptable limit of 10%. This statistical data represents data of only group 3 A3L15 (number of subject analyzed= 90).
|
|||||||||||||||||||||||||||||||||||||||
Comparison groups |
DTaP-IPV-HB-PRP~T Vaccine v Group 3 A3L15
|
|||||||||||||||||||||||||||||||||||||||
Number of subjects included in analysis |
290
|
|||||||||||||||||||||||||||||||||||||||
Analysis specification |
Pre-specified
|
|||||||||||||||||||||||||||||||||||||||
Analysis type |
non-inferiority | |||||||||||||||||||||||||||||||||||||||
Method |
||||||||||||||||||||||||||||||||||||||||
Parameter type |
percentage of subjects | |||||||||||||||||||||||||||||||||||||||
Point estimate |
90
|
|||||||||||||||||||||||||||||||||||||||
Confidence interval |
||||||||||||||||||||||||||||||||||||||||
level |
95% | |||||||||||||||||||||||||||||||||||||||
sides |
2-sided
|
|||||||||||||||||||||||||||||||||||||||
lower limit |
81.9 | |||||||||||||||||||||||||||||||||||||||
upper limit |
95.3 | |||||||||||||||||||||||||||||||||||||||
Statistical analysis title |
Non-inferiority analysis of antiPolio-1 antibodies | |||||||||||||||||||||||||||||||||||||||
Statistical analysis description |
Non-inferiority concluded if the lower limit of the two-sided 95% CI for the rates observed 30 days after the third infant series dose in A3L35 lies entirely above the reference value (rates observed 30 days after the third dose in Group 3 of A3L15) minus the clinical acceptable limit of 10%. This statistical data represents data of only group 3 A3L15 (number of subject analyzed= 104).
|
|||||||||||||||||||||||||||||||||||||||
Comparison groups |
DTaP-IPV-HB-PRP~T Vaccine v Group 3 A3L15
|
|||||||||||||||||||||||||||||||||||||||
Number of subjects included in analysis |
290
|
|||||||||||||||||||||||||||||||||||||||
Analysis specification |
Pre-specified
|
|||||||||||||||||||||||||||||||||||||||
Analysis type |
non-inferiority | |||||||||||||||||||||||||||||||||||||||
Method |
||||||||||||||||||||||||||||||||||||||||
Parameter type |
percentage of subjects | |||||||||||||||||||||||||||||||||||||||
Point estimate |
99
|
|||||||||||||||||||||||||||||||||||||||
Confidence interval |
||||||||||||||||||||||||||||||||||||||||
level |
95% | |||||||||||||||||||||||||||||||||||||||
sides |
2-sided
|
|||||||||||||||||||||||||||||||||||||||
lower limit |
94.8 | |||||||||||||||||||||||||||||||||||||||
upper limit |
100 | |||||||||||||||||||||||||||||||||||||||
Statistical analysis title |
Non-inferiority analysis of antiPolio-2 antibodies | |||||||||||||||||||||||||||||||||||||||
Statistical analysis description |
Non-inferiority concluded if the lower limit of the two-sided 95% CI for the rates observed 30 days after the third infant series dose in A3L35 lies entirely above the reference value (rates observed 30 days after the third dose in Group 3 of A3L15) minus the clinical acceptable limit of 10%. This statistical data represents data of only group 3 A3L15 (number of subject analyzed= 113).
|
|||||||||||||||||||||||||||||||||||||||
Comparison groups |
DTaP-IPV-HB-PRP~T Vaccine v Group 3 A3L15
|
|||||||||||||||||||||||||||||||||||||||
Number of subjects included in analysis |
290
|
|||||||||||||||||||||||||||||||||||||||
Analysis specification |
Pre-specified
|
|||||||||||||||||||||||||||||||||||||||
Analysis type |
non-inferiority | |||||||||||||||||||||||||||||||||||||||
Method |
||||||||||||||||||||||||||||||||||||||||
Parameter type |
percentage of subjects | |||||||||||||||||||||||||||||||||||||||
Point estimate |
98.2
|
|||||||||||||||||||||||||||||||||||||||
Confidence interval |
||||||||||||||||||||||||||||||||||||||||
level |
95% | |||||||||||||||||||||||||||||||||||||||
sides |
2-sided
|
|||||||||||||||||||||||||||||||||||||||
lower limit |
93.8 | |||||||||||||||||||||||||||||||||||||||
upper limit |
99.8 | |||||||||||||||||||||||||||||||||||||||
Statistical analysis title |
Non-inferiority analysis of antiPolio-3 antibodies | |||||||||||||||||||||||||||||||||||||||
Statistical analysis description |
Non-inferiority concluded if the lower limit of the two-sided 95% CI for the rates observed 30 days after the third infant series dose in A3L35 lies entirely above the reference value (rates observed 30 days after the third dose in Group 3 of A3L15) minus the clinical acceptable limit of 10%. This statistical data represents data of only group 3 A3L15 (number of subject analyzed= 98).
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Comparison groups |
DTaP-IPV-HB-PRP~T Vaccine v Group 3 A3L15
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Number of subjects included in analysis |
290
|
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Analysis specification |
Pre-specified
|
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Analysis type |
non-inferiority | |||||||||||||||||||||||||||||||||||||||
Method |
||||||||||||||||||||||||||||||||||||||||
Parameter type |
percentage of subjects | |||||||||||||||||||||||||||||||||||||||
Point estimate |
100
|
|||||||||||||||||||||||||||||||||||||||
Confidence interval |
||||||||||||||||||||||||||||||||||||||||
level |
95% | |||||||||||||||||||||||||||||||||||||||
sides |
2-sided
|
|||||||||||||||||||||||||||||||||||||||
lower limit |
96.3 | |||||||||||||||||||||||||||||||||||||||
upper limit |
100 | |||||||||||||||||||||||||||||||||||||||
Statistical analysis title |
Non-inferiority analysis of anti-Hep B antibodies | |||||||||||||||||||||||||||||||||||||||
Statistical analysis description |
Non-inferiority concluded if the lower limit of the two-sided 95% CI for the rates observed 30 days after the third infant series dose in A3L35 lies entirely above the reference value (rates observed 30 days after the third dose in Group 3 of A3L15) minus the clinical acceptable limit of 10%. This statistical data represents data of only group 3 A3L15 (number of subject analyzed= 98).
|
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Comparison groups |
DTaP-IPV-HB-PRP~T Vaccine v Group 3 A3L15
|
|||||||||||||||||||||||||||||||||||||||
Number of subjects included in analysis |
290
|
|||||||||||||||||||||||||||||||||||||||
Analysis specification |
Pre-specified
|
|||||||||||||||||||||||||||||||||||||||
Analysis type |
non-inferiority | |||||||||||||||||||||||||||||||||||||||
Method |
||||||||||||||||||||||||||||||||||||||||
Parameter type |
percentage of subjects | |||||||||||||||||||||||||||||||||||||||
Point estimate |
99
|
|||||||||||||||||||||||||||||||||||||||
Confidence interval |
||||||||||||||||||||||||||||||||||||||||
level |
95% | |||||||||||||||||||||||||||||||||||||||
sides |
2-sided
|
|||||||||||||||||||||||||||||||||||||||
lower limit |
94.4 | |||||||||||||||||||||||||||||||||||||||
upper limit |
100 | |||||||||||||||||||||||||||||||||||||||
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Adverse events information
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Timeframe for reporting adverse events |
Solicited reactions were collected up to Day 7 after each injection, non-serious unsolicited adverse events (AEs) were collected up to Day 30 after each injection, and serious AEs were collected throughout the study period.
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Adverse event reporting additional description |
Solicited reaction: AE prelisted in eCRF, considered related to vaccination. A solicited reaction was therefore, an adverse drug reaction observed, reported under conditions (nature and onset) prelisted in the eCRF. Unsolicited AE: an observed AE that does not fulfill conditions prelisted in eCRF in terms of symptom and/or onset post-vaccination.
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Assessment type |
Systematic | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
17.0
|
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Reporting groups
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Reporting group title |
DTaP-IPV-HB-PRP~T Vaccine: Infant Series
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Reporting group description |
Subjects received 3 doses of 0.5 mL DTaP-IPV-HB-PRP~T combined vaccine, intramuscularly, at 2, 3 and 4 months of age. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
DTaP-IPV-HB-PRP~T Vaccine: Booster Vaccination
|
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Reporting group description |
Subjects received a booster dose of 0.5 mL DTaP-IPV-HB-PRP~T combined vaccine, intramuscularly, approximately 12 months after the completion of the Infant Series (at 16 to 17 months of age). | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Frequency threshold for reporting non-serious adverse events: 5% | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
|||
| Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
||
17 Mar 2014 |
• A brief presentation of the commercialization status of hexavalent vaccines in the world and the advantages of the Sanofi Pasteur’s hexavalent vaccine, if any, over other commercialized combined vaccines from Italy or United States was added in the Introduction section.
• Since it was possible that the number of enrolled subjects was not achieved, the rule of three could be used in data analyses and this had been briefly explained.
• Clarification on the fact that the insurance coverage cases at the end of study involvement for all subjects, with the exception of insurance coverage for subjects who reported an SAE during the trial that was determined to be related to study vaccines by the Investigator (insurance coverage was continued for these subjects until the SAE is resolved).
|
||
25 Aug 2014 |
• A booster dose was added to evaluate Ab persistence after 1 year.
• A non-inferiority test comparing the immune response to all antigens induced by the study vaccine in Vietnam versus the response outside Vietnam was added.
• The booster objective was added.
• A booster endpoint was added.
|
||
16 Feb 2016 |
• A new Regional Director Of Medical Affairs was appointed.
• The timelines were updated.
• Clarification on the fact that reportable medications were to be collected in the CRF from the day of each vaccination up to the end of the safety follow-up, and that there was no collection between V4 and V5.
• Restricted use therapies and non-authorized therapies were not to be collected anymore.
|
||
07 Mar 2016 |
Correction and clarification of the booster endpoints for PT and FHA were made. |
||
Interruptions (globally) |
|||
| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
|||
| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| None reported | |||
