Clinical Trial Results:
A Phase 3, Randomized, Multicenter, Observer-Blinded, Noninferiority Study to Evaluate the Immunogenicity and Safety of a Seqirus Quadrivalent Inactivated Influenza Virus Vaccine (Seqirus QIV) with a US-Licensed 2015-2016 Quadrivalent Inactivated Comparator Influenza Vaccine (Comparator QIV) in a Pediatric Population Aged 5 Through 17 Years of Age.
|
Summary
|
|
EudraCT number |
2016-004133-25 |
Trial protocol |
Outside EU/EEA |
Global end of trial date |
13 Jun 2016
|
|
Results information
|
|
Results version number |
v1(current) |
This version publication date |
29 Mar 2017
|
First version publication date |
29 Mar 2017
|
Other versions |
|
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
|
|||
|
Trial identification
|
|||
Sponsor protocol code |
CSLCT-QIV-13-02
|
||
|
Additional study identifiers
|
|||
ISRCTN number |
- | ||
US NCT number |
NCT02545543 | ||
WHO universal trial number (UTN) |
- | ||
|
Sponsors
|
|||
Sponsor organisation name |
Seqirus
|
||
Sponsor organisation address |
45 Sidney Street, Cambridge MA, United States, 02139
|
||
Public contact |
Seqirus Clinical Trials, Seqirus, Seqirus.ClinicalTrials@Seqirus.com
|
||
Scientific contact |
Seqirus Clinical Trials, Seqirus, Seqirus.ClinicalTrials@Seqirus.com
|
||
|
Paediatric regulatory details
|
|||
Is trial part of an agreed paediatric investigation plan (PIP) |
Yes
|
||
EMA paediatric investigation plan number(s) |
EMEA-001894-PIP01-15 | ||
Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
|
||
Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
|
||
|
Results analysis stage
|
|||
Analysis stage |
Final
|
||
Date of interim/final analysis |
21 Sep 2016
|
||
Is this the analysis of the primary completion data? |
No
|
||
Global end of trial reached? |
Yes
|
||
Global end of trial date |
13 Jun 2016
|
||
Was the trial ended prematurely? |
No
|
||
|
General information about the trial
|
|||
Main objective of the trial |
To demonstrate that vaccination with Seqirus QIV elicits an immune response that is not inferior to that of a US licensed comparator QIV containing the same virus strains as Seqirus QIV, among a pediatric population 5 through 17 years of age.
|
||
Protection of trial subjects |
This clinical study was designated, implemented and reported in accordance with the International Conference on Harmonization (ICH) Harmonized Tripartite Guidelines for Good Clinical Practice (GCP), with applicable local regulations, and with the ethical principles laid down in the Declaration of Helsinki.
|
||
Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
14 Sep 2015
|
||
Long term follow-up planned |
Yes
|
||
Long term follow-up rationale |
Safety | ||
Long term follow-up duration |
10 Months | ||
Independent data monitoring committee (IDMC) involvement? |
Yes
|
||
|
Population of trial subjects
|
|||
Number of subjects enrolled per country |
|||
Country: Number of subjects enrolled |
United States: 2278
|
||
Worldwide total number of subjects |
2278
|
||
EEA total number of subjects |
0
|
||
Number of subjects enrolled per age group |
|||
In utero |
0
|
||
Preterm newborn - gestational age < 37 wk |
0
|
||
Newborns (0-27 days) |
0
|
||
Infants and toddlers (28 days-23 months) |
0
|
||
Children (2-11 years) |
655
|
||
Adolescents (12-17 years) |
1623
|
||
Adults (18-64 years) |
0
|
||
From 65 to 84 years |
0
|
||
85 years and over |
0
|
||
|
|||||||||||||||||||||||||||||||
|
Recruitment
|
|||||||||||||||||||||||||||||||
Recruitment details |
First Patient In: 14-SEP-2015, Last Patient Last Visit: 13-JUN-2016. Number of activated sites that enrolled subjects: 32 (all based in USA) | ||||||||||||||||||||||||||||||
|
Pre-assignment
|
|||||||||||||||||||||||||||||||
Screening details |
Number of subjects screened: 2349. Number of subjects randomized: 2278 | ||||||||||||||||||||||||||||||
|
Period 1
|
|||||||||||||||||||||||||||||||
Period 1 title |
Overall Trial (overall period)
|
||||||||||||||||||||||||||||||
Is this the baseline period? |
Yes | ||||||||||||||||||||||||||||||
Allocation method |
Randomised - controlled
|
||||||||||||||||||||||||||||||
Blinding used |
Double blind | ||||||||||||||||||||||||||||||
Roles blinded |
Investigator, Carer, Assessor, Subject | ||||||||||||||||||||||||||||||
|
Arms
|
|||||||||||||||||||||||||||||||
Are arms mutually exclusive |
Yes
|
||||||||||||||||||||||||||||||
|
Arm title
|
Seqirus Quadrivalent Influenza Vaccine | ||||||||||||||||||||||||||||||
Arm description |
The Seqirus study vaccine is a sterile, thiomersal-free suspension containing 60 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the four recommended influenza strains for the Northern Hemisphere 2015/2016 influenza season). | ||||||||||||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||||||||||||
Investigational medicinal product name |
Seqirus Quadrivalent Inactivated Influenza Vaccine (Seqirus QIV)
|
||||||||||||||||||||||||||||||
Investigational medicinal product code |
|||||||||||||||||||||||||||||||
Other name |
|||||||||||||||||||||||||||||||
Pharmaceutical forms |
Suspension for injection
|
||||||||||||||||||||||||||||||
Routes of administration |
Intramuscular use
|
||||||||||||||||||||||||||||||
Dosage and administration details |
Seqirus QIV, inactivated, split-virion, thimerosal-free, quadrivalent influenza vaccine, administered as a 0.5 mL intramuscular dose. The vaccine is presented in a prefilled needleless syringe.
|
||||||||||||||||||||||||||||||
|
Arm title
|
Comparator Quadrivalent Influenza Vaccine | ||||||||||||||||||||||||||||||
Arm description |
The Comparator Quadrivalent Inactivated Influenza vaccine is a US-licensed product containing four recommended influenza strains for the Northern Hemisphere 2015/2016 influenza season. | ||||||||||||||||||||||||||||||
Arm type |
Active comparator | ||||||||||||||||||||||||||||||
Investigational medicinal product name |
Comparator Quadrivalent Influenza Vaccine (Comparator QIV)
|
||||||||||||||||||||||||||||||
Investigational medicinal product code |
|||||||||||||||||||||||||||||||
Other name |
|||||||||||||||||||||||||||||||
Pharmaceutical forms |
Suspension for injection
|
||||||||||||||||||||||||||||||
Routes of administration |
Intramuscular use
|
||||||||||||||||||||||||||||||
Dosage and administration details |
The US-licensed Comparator QIV, inactivated, split-virion, thimerosal-free, quadrivalent influenza vaccine, administered as a 0.5 mL intramuscular dose. The vaccine is presented in a prefilled needleless syringe.
|
||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||
|
Baseline characteristics reporting groups
|
|||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Seqirus Quadrivalent Influenza Vaccine
|
||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
The Seqirus study vaccine is a sterile, thiomersal-free suspension containing 60 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the four recommended influenza strains for the Northern Hemisphere 2015/2016 influenza season). | ||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Comparator Quadrivalent Influenza Vaccine
|
||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
The Comparator Quadrivalent Inactivated Influenza vaccine is a US-licensed product containing four recommended influenza strains for the Northern Hemisphere 2015/2016 influenza season. | ||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||
|
|||
|
End points reporting groups
|
|||
Reporting group title |
Seqirus Quadrivalent Influenza Vaccine
|
||
Reporting group description |
The Seqirus study vaccine is a sterile, thiomersal-free suspension containing 60 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the four recommended influenza strains for the Northern Hemisphere 2015/2016 influenza season). | ||
Reporting group title |
Comparator Quadrivalent Influenza Vaccine
|
||
Reporting group description |
The Comparator Quadrivalent Inactivated Influenza vaccine is a US-licensed product containing four recommended influenza strains for the Northern Hemisphere 2015/2016 influenza season. | ||
Subject analysis set title |
Per-protocol population
|
||
Subject analysis set type |
Per protocol | ||
Subject analysis set description |
The Per-Protocol Population comprised all subjects in the Evaluable Population who did not have any protocol deviations that were medically assessed as potentially impacting on immunogenicity results.
|
||
|
|||||||||||||||||
End point title |
The Geometric Mean Titre (GMT) ratio of each virus strain (Comparator QIV over Seqirus QIV) [1] | ||||||||||||||||
End point description |
Noninferiority of Seqirus QIV compared to comparator QIV was assessed by the eight co-primary endpoints of hemagglutination inhibition (HI) antibody geometric mean titer (GMT) and seroconversion rate (SCR) for each viral strain included in the vaccines. The GMT ratio is defined as the geometric mean of the postvaccination HI titer for the US-licensed comparator QIV over the geometric mean of the postvaccination HI titer for Seqirus QIV.
The noninferiority criterion for the GMT ratio (adjusted analysis) was that the upper bound of the two-sided 95% CI of the GMT ratio for the Comparator QIV GMT, divided by the bioCSL QIV GMT, should not exceed 1.5.
Analysis Population Description: The Per Protocol Population was used for the primary and secondary analysis of immunogenicity data and included subjects in the Evaluable Population minus any subjects with deviations that were thought to potentially affect the immunogenicity results, following medical review prior to unblinding.
|
||||||||||||||||
End point type |
Primary
|
||||||||||||||||
End point timeframe |
28 days after last vaccination
|
||||||||||||||||
| 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: Noninferiority analysis by GMT Ratios: The noninferiority criterion for the GMT ratio was that the upper bound of the two-sided 95% CI of the GMT ratio for the Comparator QIV GMT, divided by the Seqirus QIV GMT, should not exceed 1.5. |
|||||||||||||||||
|
|||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||
|
|||||||||||||||||
End point title |
The difference in Seroconversion Rates (SCR) for each virus strain (Comparator QIV minus Seqirus QIV) [2] | ||||||||||||||||
End point description |
Noninferiority of Seqirus QIV compared to Comparator QIV was assessed by the eight co-primary endpoints of HI geometric mean titer (GMT) and seroconversion rate (SCR) for each viral strain. The rate of SCR is defined as the percentage of subjects with either a prevaccination HI titer < 1:10 and a postvaccination HI titer ≥ 1:40, or a prevaccination HI titer ≥ 1:10 and a ≥ 4-fold increase in postvaccination HI titer. For the SCR comparison, the difference between the SCR for each virus strain will be determined.
The noninferiority criterion for the SCR difference was that the upper bound of the two-sided 95% CI on the difference between SCRs for Comparator QIV minus the bioCSL QIV SCR should not exceed 10%.
Analysis Population Description: The Per Protocol Population was used for the primary and secondary analysis of immunogenicity data and included subjects in the Evaluable Population minus any subjects with deviations that were thought to potentially affect the immunogenicity r
|
||||||||||||||||
End point type |
Primary
|
||||||||||||||||
End point timeframe |
28 days after last vaccination
|
||||||||||||||||
| 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: Noninferiority analysis by Seroconversion Rates: The noninferiority criterion for the SCR difference was that the upper bound of the two-sided 95% CI on the difference between SCRs for Comparator QIV minus the Seqirus QIV SCR should not exceed 10%. |
|||||||||||||||||
|
|||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||
|
|||||||||||||||||||
End point title |
Safety Endpoint: The Frequency and Severity of Solicited Local Adverse Reactions (AEs) | ||||||||||||||||||
End point description |
Frequency and severity of solicited local adverse reactions (AEs) for 7 days (ie, day of vaccination and 6 subsequent days) after each vaccination dose
Analysis Population Description: The Solicited Safety Population comprises all subjects in the FAS who received at least one dose or partial dose of Study Vaccine and provided any
evaluable data on solicited events.
|
||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||
End point timeframe |
7 days after each vaccination
|
||||||||||||||||||
|
|||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||
|
|||||||||||||||||||
End point title |
Safety Endpoint: The Frequency and Severity of Solicited Systemic Adverse Events (AEs). | ||||||||||||||||||
End point description |
Frequency and severity of solicited systemic adverse events (AEs) for 7 days (ie, day of vaccination and 6 subsequent days) after each vaccination dose
Analysis Population Description: The Solicited Safety Population comprised all subjects in the FAS who received at least one dose or partial dose of Study Vaccine and provided any evaluable data on solicited events.
|
||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||
End point timeframe |
7 days after each vaccination
|
||||||||||||||||||
|
|||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||
|
|||||||||||||
End point title |
Safety Endpoint: The Frequency of Cellulitis-like Reaction | ||||||||||||
End point description |
Frequency of cellulitis-like reaction for at least 28 days after each vaccination dose
Analysis Population Description: The Solicited Safety Population comprises all subjects in the FAS who received at least one dose or partial dose of Study Vaccine and provided any evaluable data on solicited events.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
28 days after each vaccination.
|
||||||||||||
|
|||||||||||||
| No statistical analyses for this end point | |||||||||||||
|
|||||||||||||||||||
End point title |
Safety Endpoint: The Frequency and Severity of Unsolicited Adverse Events (AEs). | ||||||||||||||||||
End point description |
Frequency and severity of unsolicited AEs for at least 28 days (ie, day of vaccination and 27 subsequent days) after each vaccination dose
Analysis Population Description: The Overall Safety Population comprises all subjects in the FAS who received at least one dose or partial dose of Study Vaccine and provided any evaluable
follow-up safety data.
|
||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||
End point timeframe |
28 days after each vaccination
|
||||||||||||||||||
|
|||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||
|
|||||||||||||
End point title |
Safety Endpoint: The Frequency of Serious Adverse Events (SAEs). | ||||||||||||
End point description |
Frequency of serious adverse events (SAEs) for 180 days after the last vaccination dose
Analysis Population Description: The Overall Safety Population comprises all subjects in the FAS who received at least one dose or partial dose of Study Vaccine and provided any evaluable
follow-up safety data
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
180 days after the last vaccination dose.
|
||||||||||||
|
|||||||||||||
| No statistical analyses for this end point | |||||||||||||
|
|||||||||||||||||||||||||||||||||||||
End point title |
Immunogenicity Endpoint: GMTs - Geometric Mean of HI Titers Prevaccination (Day 1) and Postvaccination (Study Exit Visit) | ||||||||||||||||||||||||||||||||||||
End point description |
The humoral immune response was assessed for Seqirus QIV & comparator QIV. Serum HI titers against the 4 influenza vaccine strains was used to calculate Geometric mean of HI titers prevaccination & postvaccination
Analysis Population Description: The Per-Protocol Population comprised all subjects in the Evaluable Population who did not have any protocol deviations that were medically assessed as potentially impacting on immunogenicity results
|
||||||||||||||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||||||||||||||
End point timeframe |
28 days after last vaccination
|
||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||
End point title |
Immunogenicity Endpoint: Seroconversion Rate (SCR) | ||||||||||||||||||||||||
End point description |
The humoral immune response was assessed for Seqirus QIV & comparator QIV. Serum HI titers against the 4 influenza vaccine strains was used to calculate SCRs: % of subjects with either a prevaccination HI titer < 1:10 and a postvaccination HI titer ≥ 1:40 or a prevaccination titer ≥ 1:10 and a ≥ 4-fold increase in postvaccination titer
Analysis Population Description: The Per-Protocol Population comprised all subjects in the Evaluable Population who did not have any protocol deviations that were medically assessed as potentially impacting on immunogenicity results
|
||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||
End point timeframe |
28 days after last vaccination
|
||||||||||||||||||||||||
|
|||||||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||
End point title |
Immunogenicity Endpoint: Seroprotection Rate | ||||||||||||||||||||||||||||||||||||
End point description |
The humoral immune response was assessed for Seqirus QIV & comparator QIV. Serum HI titers against the 4 influenza vaccine strains was used to calculate the % of subjects with a titer ≥40 (seroprotection rates) at Day 1 and at Exit Visit
Analysis Population Description: The Per-Protocol Population comprised all subjects in the Evaluable Population who did not have any protocol deviations that were medically assessed as potentially impacting on immunogenicity results
|
||||||||||||||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||||||||||||||
End point timeframe |
28 days after last vaccination
|
||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||
End point title |
Immunogenicity Endpoint: Geometric Mean Fold Increase (GMFI) | ||||||||||||||||||||||||
End point description |
The humoral immune response was assessed for Seqirus QIV & comparator QIV. Serum HI titers against the 4 influenza vaccine strains was used to calculate Geometric mean fold increase (GMFI): geometric mean fold titer rise from Day 1 to Exit Visit
Analysis Population Description: The Per-Protocol Population comprised all subjects in the Evaluable Population who did not have any protocol deviations that were medically assessed as potentially impacting on immunogenicity results.
|
||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||
End point timeframe |
28 days after last vaccination
|
||||||||||||||||||||||||
|
|||||||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
Adverse events information
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Timeframe for reporting adverse events |
Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after each vaccination dose. SAEs collected for 180 days after last vaccination.
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
Dictionary used for adverse event reporting
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
17
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
Reporting groups
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Seqirus Quadrivalent Influenza Vaccine
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
The Seqirus study vaccine is a sterile, thiomersal-free suspension containing 60 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the four recommended influenza strains for the Northern Hemisphere 2015/2016 influenza season). | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Comparator Quadrivalent Influenza Vaccine
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
The Comparator Quadrivalent Inactivated Influenza vaccine is a US-licensed product containing four recommended influenza strains for the Northern Hemisphere 2015/2016 influenza season. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Frequency threshold for reporting non-serious adverse events: 3% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||
Substantial protocol amendments (globally) |
|||
| Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
||
05 Aug 2015 |
Protocol amendment 1 (dated 05 Aug 2015), made the following revisions:
1) To clarify definitions of secondary safety endpoints;
2) To clarify when screening evaluations can be performed;
3) To adjust inclusion criterion to require ability of parent/guardian to use a Smartphone or computer to complete the eDiaries;
4) To clarify exclusion criterion concerning active infection or fever on day of vaccination;
5) To clarify exclusion criterion concerning current or recent medical conditions;
6) To add administration of second vaccination in procedures list for Visit 2, 2-dose group;
7) To clarify composition of the Safety Population;
8) To add instructions on postponing vaccination in the event of a febrile illness (oral temperature 100.0°F [37.8°C] or higher) or prophylactic antipyretic use on the day of vaccination;
9) To add instructions on retention of samples as requested by the IRB;
10) To remove reference to oral temperature and body weight as clinical signs;
11) To correct minor grammatical and typographic errors
|
||
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 | |||
