Clinical Trial Results:
Immunogenicity and Safety of Fractional Booster Dose of sanofi pasteur’s Inactivated Poliomyelitis Vaccine (IMOVAX Polio) Administered Intradermally versus Full Booster Dose of Inactivated Poliomyelitis Vaccine (IMOVAX Polio) Administered Intramuscularly at 15 to 18 Months of Age in Healthy Toddlers in The Philippines
Summary
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EudraCT number |
2015-005184-16 |
Trial protocol |
Outside EU/EEA |
Global end of trial date |
28 Jul 2009
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Results information
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Results version number |
v1(current) |
This version publication date |
16 Apr 2016
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First version publication date |
16 Apr 2016
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Other versions |
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 |
IPV26
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT00885157 | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
Sanofi Pasteur SA
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Sponsor organisation address |
2, avenue Pont Pasteur, Lyon cedex 07, France, F-69367
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Public contact |
Franchise Medical Director, Sanofi Pasteur SA, 33 4 37 65 67 99, Emmanuel.Vidor@sanofipasteur.com
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Scientific contact |
Franchise Medical Director, Sanofi Pasteur SA, 33 4 37 65 67 99, Emmanuel.Vidor@sanofipasteur.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 |
11 Jan 2010
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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 |
28 Jul 2009
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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 in each group the immunogenicity of IMOVAX Polio administered intradermally or intramuscularly, one month after the booster dose given at 15-18 months of age in toddlers previously primed with three doses of IMOVAX Polio vaccine during the IPV25 study
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Protection of trial subjects |
Only subjects that met all the study inclusion and none of the exclusion criteria were randomized and vaccinated in the study. 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 was also available on site in case of any immediate allergic reactions.
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Background therapy |
This study was designed to assess the immunogenicity and safety of a fractional booster dose of IMOVAX Polio administered intradermally, compared to a full booster dose of IMOVAX Polio administered intramuscularly, at 15 to 18 months of age, after a three-dose primary vaccination series during the IPV25 study. | ||
Evidence for comparator |
Not applicable | ||
Actual start date of recruitment |
07 Apr 2009
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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 |
Philippines: 225
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Worldwide total number of subjects |
225
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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) |
225
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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 from 07 April 2009 to 25 June 2009 at 1 clinic center in the Philippines. | |||||||||||||||
Pre-assignment
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Screening details |
A total of 225 subjects who met all inclusion and none of the exclusion criteria were enrolled and vaccinated in this study. | |||||||||||||||
Period 1
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Period 1 title |
Overall trial (overall period)
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Is this the baseline period? |
Yes | |||||||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Not blinded | |||||||||||||||
Blinding implementation details |
Not applicable
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Fractional Dose of IMOVAX Polio™ | |||||||||||||||
Arm description |
Toddlers received Inactivated Poliomyelitis Vaccine (IMOVAX Polio™) intradermally as primary vaccination series (IPV25) and received a fractional booster dose (0.1 mL or 1/5 of full dose) of Inactivated Poliomyelitis Vaccine (IMOVAX Polio™) intradermally between 15 and 18 months of age. Toddlers also received concomitant DTw-Hib vaccine (TETRAct-HIb®) between 12 and 24 months of age. | |||||||||||||||
Arm type |
Experimental | |||||||||||||||
Investigational medicinal product name |
IPV (IMOVAX Polio™)
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Suspension for injection
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Routes of administration |
Intradermal use
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Dosage and administration details |
0.1 mL, intradermal into the right upper arm using the Mantoux technique, 1 booster dose.
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Arm title
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Full Dose of IMOVAX Polio™ | |||||||||||||||
Arm description |
Toddlers received Inactivated Poliomyelitis Vaccine (IMOVAX Polio™) intramuscularly as primary vaccination series (IPV25) and received a full booster dose (0.5mL) of Inactivated Poliomyelitis Vaccine (IMOVAX Polio™) intramuscularly between 15 and 18 months of age. Toddlers also received concomitant DTw-Hib vaccine (TETRAct-HIb®) between 12 and 24 months of age. | |||||||||||||||
Arm type |
Active comparator | |||||||||||||||
Investigational medicinal product name |
IPV (IMOVAX Polio™)
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Suspension for injection
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Routes of administration |
Intramuscular use
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Dosage and administration details |
0.5 mL, intradermal into the anterolateral, 1 booster dose.
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Baseline characteristics reporting groups
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Reporting group title |
Fractional Dose of IMOVAX Polio™
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Reporting group description |
Toddlers received Inactivated Poliomyelitis Vaccine (IMOVAX Polio™) intradermally as primary vaccination series (IPV25) and received a fractional booster dose (0.1 mL or 1/5 of full dose) of Inactivated Poliomyelitis Vaccine (IMOVAX Polio™) intradermally between 15 and 18 months of age. Toddlers also received concomitant DTw-Hib vaccine (TETRAct-HIb®) between 12 and 24 months of age. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Full Dose of IMOVAX Polio™
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Reporting group description |
Toddlers received Inactivated Poliomyelitis Vaccine (IMOVAX Polio™) intramuscularly as primary vaccination series (IPV25) and received a full booster dose (0.5mL) of Inactivated Poliomyelitis Vaccine (IMOVAX Polio™) intramuscularly between 15 and 18 months of age. Toddlers also received concomitant DTw-Hib vaccine (TETRAct-HIb®) between 12 and 24 months of age. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Fractional Dose of IMOVAX Polio™
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Reporting group description |
Toddlers received Inactivated Poliomyelitis Vaccine (IMOVAX Polio™) intradermally as primary vaccination series (IPV25) and received a fractional booster dose (0.1 mL or 1/5 of full dose) of Inactivated Poliomyelitis Vaccine (IMOVAX Polio™) intradermally between 15 and 18 months of age. Toddlers also received concomitant DTw-Hib vaccine (TETRAct-HIb®) between 12 and 24 months of age. | ||
Reporting group title |
Full Dose of IMOVAX Polio™
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Reporting group description |
Toddlers received Inactivated Poliomyelitis Vaccine (IMOVAX Polio™) intramuscularly as primary vaccination series (IPV25) and received a full booster dose (0.5mL) of Inactivated Poliomyelitis Vaccine (IMOVAX Polio™) intramuscularly between 15 and 18 months of age. Toddlers also received concomitant DTw-Hib vaccine (TETRAct-HIb®) between 12 and 24 months of age. |
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End point title |
Percentage of Infant Subjects with Anti-Poliovirus 1, 2 and 3 Titers of 1 ≥4 (1/dil) or 1 ≥8 (1/dil) Before and Following Vaccination with Either A Fractional Booster-Dose Or A Full Booster-Dose of Inactivated Poliomyelitis Vaccine (IMOVAX Polio™) [1] | ||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
Anti-Poliovirus types 1, 2, and 3 were measured by neutralization assay.
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End point type |
Primary
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End point timeframe |
Pre- and Post-booster
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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: Descriptive analyses were performed based on the study groups and the study vaccine administered for this outcome. |
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No statistical analyses for this end point |
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End point title |
Geometric Mean Titers of Anti-Polio 1, 2, and 3 Antibodies Before and Following Vaccination with Either A Fractional Booster-Dose Or A Full Booster-Dose of Inactivated Poliomyelitis Vaccine (IMOVAX Polio™) [2] | ||||||||||||||||||||||||||||||
End point description |
Anti-Poliovirus types 1, 2, and 3 were measured by neutralization assay.
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End point type |
Primary
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End point timeframe |
Pre- and Post-booster
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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: Descriptive analyses were performed based on the study groups and the study vaccine administered for this outcome. |
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No statistical analyses for this end point |
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End point title |
Geometric Mean Titer Ratios of Anti-Polio 1, 2, and 3 Antibodies Following Vaccination with Either A Fractional Booster-Dose Or A Full Booster-Dose of Inactivated Poliomyelitis Vaccine (IMOVAX Polio™) [3] | |||||||||||||||||||||
End point description |
Anti-Poliovirus types 1, 2, and 3 were measured by neutralization assay.
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End point type |
Primary
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End point timeframe |
Post-/Pre-Booster
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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: Descriptive analyses were performed based on the study groups and the study vaccine administered for this outcome. |
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No statistical analyses for this end point |
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End point title |
Percentage of Infant Subjects with ≥4-fold increase of Anti-Polio 1, 2, and 3 Antibodies Following Vaccination with Either A Fractional Booster-Dose Or A Full Booster-Dose of Inactivated Poliomyelitis Vaccine (IMOVAX Polio™) [4] | |||||||||||||||||||||
End point description |
Anti-Poliovirus types 1, 2, and 3 were measured by neutralization assay.
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End point type |
Primary
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End point timeframe |
Post-booster
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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: Descriptive analyses were performed based on the study groups and the study vaccine administered for this outcome. |
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No statistical analyses for this end point |
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End point title |
Percentage of Infant Subjects with Solicited Injection-site and Systemic Reactions Following Vaccination with Either A Fractional Booster-Dose Or A Full Booster-Dose of Inactivated Poliomyelitis Vaccine (IMOVAX Polio™) [5] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
Solicited Injection site reactions: Tenderness, Erythema, Swelling. Solicited systemic reactions: Fever, Vomiting, Crying abnormal, Drowsiness, Appetite lost, Irritability.
Grade 3 Solicited Injection site reactions: Tenderness, Cries when injected limb is moved or the movement of the injected limb is reduced; Erythema and Swelling, ≥ 5 cm. Grade 3 Solicited systemic reactions: Fever, > 39.5°C; Vomiting, ≥ 6 episodes per 24 hours or requiring parenteral hydration; Crying abnormal, > 3 hours; Drowsiness, Sleeping most of the time or difficult to wake up; Appetite lost, Refuses ≥ 3 feeds/meals or refuses most feeds/meals; Irritability, Inconsolable.
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End point type |
Primary
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End point timeframe |
Day 0 to Day 7 post-booster
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Notes [5] - 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: Descriptive analyses were performed based on the study groups and the study vaccine administered for this outcome. |
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No statistical analyses for this end point |
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Adverse events information
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Timeframe for reporting adverse events |
Adverse event data were collected from Day 0 up to Day 7 post-booster vaccine injection.
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Assessment type |
Non-systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
9.0
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Reporting groups
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Reporting group title |
Fractional Dose of IMOVAX Polio™
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Reporting group description |
Toddlers received Inactivated Poliomyelitis Vaccine (IMOVAX Polio™) intradermally as primary vaccination series (IPV25) and received a fractional booster dose (0.1 mL or 1/5 of full dose) of Inactivated Poliomyelitis Vaccine (IMOVAX Polio™) intradermally between 15 and 18 months of age. Toddlers also received concomitant DTw-Hib vaccine (TETRAct-HIb®) between 12 and 24 months of age. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Full Dose of IMOVAX Polio™
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Reporting group description |
Toddlers received Inactivated Poliomyelitis Vaccine (IMOVAX Polio™) intramuscularly as primary vaccination series (IPV25) and received a full booster dose (0.5mL) of Inactivated Poliomyelitis Vaccine (IMOVAX Polio™) intramuscularly between 15 and 18 months of age. Toddlers also received concomitant DTw-Hib vaccine (TETRAct-HIb®) between 12 and 24 months of age. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
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Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
None reported |