Clinical Trial Results:
A Phase 4, Open-label Trial to Assess the Safety, Tolerability, and Immunogenicity of Prevenar in Older Infants and Young Children in China Who Are Naive to Previous Pneumococcal Vaccination
Summary
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EudraCT number |
2014-004178-40 |
Trial protocol |
Outside EU/EEA |
Global end of trial date |
25 Sep 2012
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Results information
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Results version number |
v1(current) |
This version publication date |
29 Jun 2016
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First version publication date |
25 Jul 2015
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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 |
B1841008
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT01193582 | ||
WHO universal trial number (UTN) |
- | ||
Other trial identifiers |
Protocol: 6114A1-4000 | ||
Sponsors
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Sponsor organisation name |
Pfizer Inc.
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Sponsor organisation address |
235 E 42nd Street, New York, United States, NY 10017
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Public contact |
Clinical Trials.gov Call Center, Pfizer Inc., 001 8007181021, linicalTrials.govInquiries@pfizer.com
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Scientific contact |
Clinical Trials.gov Call Center, Pfizer Inc., 001 8007181021, linicalTrials.govInquiries@pfizer.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 Jun 2013
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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 |
25 Sep 2012
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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 assess the serotype-specific pneumococcal immune responses induced by Prevenar when measured 1 month after the last dose of Prevenar in each age group.
To assess the pre-vaccination antibody levels to the 7 pneumococcal serotypes in Prevenar in each age group.
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Protection of trial subjects |
The study was in compliance with the ethical principles derived from the Declaration of Helsinki and in compliance with all International Conference on Harmonization (ICH) Good Clinical Practice (GCP) Guidelines. All the local regulatory requirements pertinent to safety of trial subjects were followed.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
09 Nov 2010
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Long term follow-up planned |
Yes
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Long term follow-up rationale |
Safety, Efficacy | ||
Long term follow-up duration |
12 Months | ||
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 |
China: 505
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Worldwide total number of subjects |
505
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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) |
325
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Children (2-11 years) |
180
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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 |
This report presents results following completion of all vaccinations, including data from the 12-month follow-up. This study was conducted at one site in China. | |||||||||||||||||||||||||||||||||||||||||||||
Pre-assignment
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Screening details |
Subjects were enrolled into 1 of 4 groups based on inclusion/exclusion criteria without a screening period. A total of 506 subjects were enrolled in this study, 505 received at least 1 dose of vaccine Subject disposition and baseline characteristics are represented for the treated subjects. | |||||||||||||||||||||||||||||||||||||||||||||
Period 1
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Period 1 title |
Vaccination Series
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Is this the baseline period? |
Yes | |||||||||||||||||||||||||||||||||||||||||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | |||||||||||||||||||||||||||||||||||||||||||||
Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Group 1 | |||||||||||||||||||||||||||||||||||||||||||||
Arm description |
Subjects 121 to less than (<) 212 days of age and received 4 doses of Prevenar. | |||||||||||||||||||||||||||||||||||||||||||||
Arm type |
Experimental | |||||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
7-valent Pneumococcal Conjugate Vaccine
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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 |
Subjects received 4 doses of Prevenar administered as a single 0.5 milliliter (mL) dose intramuscularly.
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Arm title
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Group 2 | |||||||||||||||||||||||||||||||||||||||||||||
Arm description |
Subjects 212 days to <12 months of age (before the first birthday) and received 3 doses of Prevenar. | |||||||||||||||||||||||||||||||||||||||||||||
Arm type |
Experimental | |||||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
7-valent Pneumococcal Conjugate Vaccine
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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 |
Subjects received 3 doses of Prevenar administered as a single 0.5 mL dose intramuscularly.
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Arm title
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Group 3 | |||||||||||||||||||||||||||||||||||||||||||||
Arm description |
Subjects 12 to <24 months of age (before the second birthday) and received 2 doses of Prevenar. | |||||||||||||||||||||||||||||||||||||||||||||
Arm type |
Experimental | |||||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
7-valent Pneumococcal Conjugate Vaccine
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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 |
Subjects received 2 doses of Prevenar administered as a single 0.5 mL dose intramuscularly.
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Arm title
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Group 4 | |||||||||||||||||||||||||||||||||||||||||||||
Arm description |
Subjects 24 to <72 months of age (before the sixth birthday) and received 1 dose of Prevenar. | |||||||||||||||||||||||||||||||||||||||||||||
Arm type |
Experimental | |||||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
7-valent Pneumococcal Conjugate Vaccine
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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 |
Subjects received single 0.5 mL intramuscular doses of Prevenar.
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Notes [1] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left. Justification: Subjects were planned to recieve only 1 dose of vaccination (Dose1). [2] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left. Justification: Subjects were planned to recieve only 2 doses of vaccination (Dose1 and Dose 2). [3] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left. Justification: Subjects were planned to recieve only 1 dose of vaccination (Dose1). [4] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left. Justification: Subjects were planned to recieve only 3 doses of vaccination (Dose1, Dose 2 and Dose 3). [5] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left. Justification: Subjects were planned to recieve only 2 doses of vaccination (Dose1 and Dose 2). [6] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left. Justification: Subjects were planned to recieve only 1 dose of vaccination (Dose1). |
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Period 2
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Period 2 title |
12 Month Follow-up
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Is this the baseline period? |
No | |||||||||||||||||||||||||||||||||||||||||||||
Allocation method |
Non-randomised - controlled
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Blinding used |
Not blinded | |||||||||||||||||||||||||||||||||||||||||||||
Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Group 1 Follow up period | |||||||||||||||||||||||||||||||||||||||||||||
Arm description |
Included subjects 121 to less than (<) 212 days of age who received 4 doses of Prevenar during vaccination series (period 1). | |||||||||||||||||||||||||||||||||||||||||||||
Arm type |
No intervention | |||||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
No investigational medicinal product assigned in this arm
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Arm title
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Group 2 Follow up period | |||||||||||||||||||||||||||||||||||||||||||||
Arm description |
Included subjects 212 days to <12 months of age (before the first birthday) who received 3 doses of Prevenar during vaccination series (period 1). | |||||||||||||||||||||||||||||||||||||||||||||
Arm type |
No intervention | |||||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
No investigational medicinal product assigned in this arm
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Arm title
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Group 3 Follow up period | |||||||||||||||||||||||||||||||||||||||||||||
Arm description |
Included subjects 12 to <24 months of age (before the second birthday) who received 2 doses of Prevenar during vaccination series (period 1). | |||||||||||||||||||||||||||||||||||||||||||||
Arm type |
No intervention | |||||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
No investigational medicinal product assigned in this arm
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Arm title
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Group 4 Follow up period | |||||||||||||||||||||||||||||||||||||||||||||
Arm description |
Included subjects 24 to <72 months of age (before the sixth birthday) who received 1 dose of Prevenar during vaccination series (period 1). | |||||||||||||||||||||||||||||||||||||||||||||
Arm type |
No intervention | |||||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
No investigational medicinal product assigned in this arm
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Baseline characteristics reporting groups
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Reporting group title |
Group 1
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Reporting group description |
Subjects 121 to less than (<) 212 days of age and received 4 doses of Prevenar. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Group 2
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Reporting group description |
Subjects 212 days to <12 months of age (before the first birthday) and received 3 doses of Prevenar. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Group 3
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Reporting group description |
Subjects 12 to <24 months of age (before the second birthday) and received 2 doses of Prevenar. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Group 4
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Reporting group description |
Subjects 24 to <72 months of age (before the sixth birthday) and received 1 dose of Prevenar. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Group 1
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Reporting group description |
Subjects 121 to less than (<) 212 days of age and received 4 doses of Prevenar. | ||
Reporting group title |
Group 2
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Reporting group description |
Subjects 212 days to <12 months of age (before the first birthday) and received 3 doses of Prevenar. | ||
Reporting group title |
Group 3
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Reporting group description |
Subjects 12 to <24 months of age (before the second birthday) and received 2 doses of Prevenar. | ||
Reporting group title |
Group 4
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Reporting group description |
Subjects 24 to <72 months of age (before the sixth birthday) and received 1 dose of Prevenar. | ||
Reporting group title |
Group 1 Follow up period
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Reporting group description |
Included subjects 121 to less than (<) 212 days of age who received 4 doses of Prevenar during vaccination series (period 1). | ||
Reporting group title |
Group 2 Follow up period
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Reporting group description |
Included subjects 212 days to <12 months of age (before the first birthday) who received 3 doses of Prevenar during vaccination series (period 1). | ||
Reporting group title |
Group 3 Follow up period
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Reporting group description |
Included subjects 12 to <24 months of age (before the second birthday) who received 2 doses of Prevenar during vaccination series (period 1). | ||
Reporting group title |
Group 4 Follow up period
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Reporting group description |
Included subjects 24 to <72 months of age (before the sixth birthday) who received 1 dose of Prevenar during vaccination series (period 1). |
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End point title |
Antibody Concentrations to the 7 Pneumococcal Serotypes Contained in Prenevar [1] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
Serotype-specific Pneumococcal Immunoglobulin G (IgG) antibody geometric mean concentration (GMC) after 1 month of last dose for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) are presented. GMC and corresponding 2-sided 95 percent (%) confidence intervals (CI) were evaluated. Geometric means (GMs) were calculated using all subjects with available data for the specified blood draw. Evaluable immunogenicity population consisted of eligible participants in the age range who had received all the assigned vaccination(s), had blood drawn within required time frames, had at least 1 valid and determinate assay result for the proposed analysis, had received no prohibited vaccines, and had no other major protocol violations.
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End point type |
Primary
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End point timeframe |
1 month after last dose in each group
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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: Only descriptive data was planned for this endpoint. |
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No statistical analyses for this end point |
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End point title |
Antibody Concentrations to the 7 Pneumococcal Serotypes Contained in Prevenar at Baseline in Each Group [2] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
End point description: Serotype-specific Pneumococcal IgG antibody GMC at baseline for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) are presented. GMC and corresponding 2-sided 95% CI were evaluated. GMs were calculated using all subjects with available data for the specified blood draw. Evaluable immunogenicity population consisted of eligible participants in the age range who had received all the assigned vaccination(s), had blood drawn within required time frames, had at least 1 valid and determinate assay result for the proposed analysis, had received no prohibited vaccines, and had no other major protocol violations.
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End point type |
Primary
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End point timeframe |
Baseline
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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: Only descriptive data was planned for this endpoint. |
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No statistical analyses for this end point |
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End point title |
Antibody Concentrations to the 7 Pneumococcal Serotypes Contained in Prevenar at 1 Month After the Third Dose in Group 1 [3] | ||||||||||||||||||||||
End point description |
Serotype-specific Pneumococcal IgG antibody GMC one month after the third dose in Group 1 for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) are presented. GMC and corresponding 2-sided 95% CI were evaluated. GMs were calculated using all with subjects available data for the specified blood draw. Evaluable immunogenicity population consisted of eligible participants in the age range who had received all the assigned vaccination(s), had blood drawn within required time frames, had at least 1 valid and determinate assay result for the proposed analysis, had received no prohibited vaccines, and had no other major protocol violations.
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End point type |
Secondary
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End point timeframe |
1 month after third dose of Prevenar in Group 1
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Notes [3] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: The endpoint was planned to be analysed to report data for Group 1 only. |
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No statistical analyses for this end point |
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End point title |
Geometric Mean Fold Rise (GMFR) of Anti-Pneumococcal Antibody Levels to the 7 Pneumococcal Serotypes Contained in Prevenar Above Vaccination Baseline Values in Group 1 . [4] | ||||||||||||||||||||||
End point description |
End point description: GMFRs for the 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) from pre-vaccination to post-vaccination were computed using the logarithmically transformed assay results. CIs for GMFR are back transformations of a CI based on the Student t-distribution for the mean logarithm of the titers. Evaluable immunogenicity population consisted of eligible subjects in the age range who had received all the assigned vaccination(s), had blood drawn within required time frames, had at least 1 valid and determinate assay result for the proposed analysis, had received no prohibited vaccines, and had no other major protocol violations.
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End point type |
Secondary
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End point timeframe |
Pre-vaccination to 1 month after third dose of Prevenar in Group 1
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Notes [4] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: The endpoint was planned to be analysed to report data for Group 1 only. |
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No statistical analyses for this end point |
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End point title |
Antibody Concentrations to the 7 Pneumococcal Serotypes Contained in Prevenar at 1 Month After the Second Dose in Group 2 [5] | ||||||||||||||||||||||
End point description |
Serotype-specific Pneumococcal IgG antibody GMC 1 month after the second dose in Group 2 for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) are presented. GMC and corresponding 2-sided 95% CI were evaluated. GMs were calculated using all participants with available data for the specified blood draw. Evaluable immunogenicity population consisted of eligible subjects in the age range who had received all the assigned vaccination(s), had blood drawn within required time frames, had at least 1 valid and determinate assay result for the proposed analysis, had received no prohibited vaccines, and had no other major protocol violations.
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End point type |
Secondary
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End point timeframe |
1 month after second dose of Prevenar in Group 2
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Notes [5] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: The endpoint was planned to be analysed to report data for Group 2 only. |
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No statistical analyses for this end point |
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End point title |
GMFR of Anti-Pneumococcal Antibody Levels to the 7 Pneumococcal Serotypes Contained in Prevenar Above Vaccination Baseline Values in Group 2 [6] | ||||||||||||||||||||||
End point description |
GMFRs for the 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) from pre-vaccination to post-vaccination were computed using the logarithmically transformed assay results. CIs for GMFR are back transformations of a CI based on the Student t-distribution for the mean logarithm of the titers. Evaluable immunogenicity population consisted of eligible subjects in the age range who had received all the assigned vaccination(s), had blood drawn within required time frames, had at least 1 valid and determinate assay result for the proposed analysis, had received no prohibited vaccines, and had no other major protocol violations.
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End point type |
Secondary
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End point timeframe |
Pre vaccination to 1 month after second dose of Prevenar in Group 2
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Notes [6] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: The endpoint was planned to be analysed to report data for Group 2 only. |
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No statistical analyses for this end point |
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End point title |
Antibody Concentrations to the 7 Pneumococcal Serotypes Contained in Prevenar at 1 Month After the First Dose in Group 3 [7] | ||||||||||||||||||||||
End point description |
Serotype-specific Pneumococcal IgG antibody GMC one month after the first dose in Group 3 for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) are presented. GMC and corresponding 2-sided 95% CI were evaluated. GMs were calculated using all participants with available data for the specified blood draw. Evaluable immunogenicity population consisted of eligible subjects in the age range who had received all the assigned vaccination(s), had blood drawn within required time frames, had at least 1 valid and determinate assay result for the proposed analysis, had received no prohibited vaccines, and had no other major protocol violations.
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End point type |
Secondary
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End point timeframe |
1 month after first dose of Prevenar in Group 3
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Notes [7] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: The endpoint was planned to be analysed to report data for Group 3 only. |
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No statistical analyses for this end point |
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End point title |
GMFR of Anti-Pneumococcal Antibody Levels to the 7 Pneumococcal Serotypes Contained in Prevenar Above Vaccination Baseline Values in Group 3 [8] | ||||||||||||||||||||||
End point description |
GMFRs for the 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) from pre-vaccination to post-vaccination were computed using the logarithmically transformed assay results. CIs for GMFR are back transformations of a CI based on the Student t-distribution for the mean logarithm of the titers. Evaluable immunogenicity population consisted of eligible subjects in the age range who had received all the assigned vaccination(s), had blood drawn within required time frames, had at least 1 valid and determinate assay result for the proposed analysis, had received no prohibited vaccines, and had no other major protocol violations.
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End point type |
Secondary
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End point timeframe |
Pre-vaccination to 1 month after first dose of Prevenar in Group 3
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Notes [8] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: The endpoint was planned to be analysed to report data for Group 3 only. |
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No statistical analyses for this end point |
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End point title |
Antibody Concentrations Against the 7 Pneumococcal Serotypes Contained in Prevenar at 12 Months After the Last Dose | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
Serotype-specific Pneumococcal IgG antibody GMC 12 months after the last dose for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) are presented. GMC and corresponding 2-sided 95% CI were evaluated. GMs were calculated using all subjects with available data for the specified blood draw. Evaluable immunogenicity population consisted subjects who had received all, assigned vaccination(s), had blood drawn within required time frame for 12 month follow-up blood draw visit, had at least 1 valid and determinate assay result, had received no prohibited vaccines, and had no major protocol violations.
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End point type |
Secondary
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End point timeframe |
12 months after the last dose
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No statistical analyses for this end point |
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End point title |
GMFR of Anti-Pneumococcal Antibody Levels to the 7 Pneumococcal Serotypes Contained in Prevenar Above Vaccination Baseline Values at 12 Months After the Last Dose | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
GMFRs for the 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) from pre-vaccination to 12- month follow-up were computed using the logarithmically transformed assay results. CIs for GMFR are back transformations of a CI based on the Student t-distribution for the mean logarithm of the titers.Evaluable immunogenicity population consisted of eligible participants in the age range who had received all the assigned vaccination(s), had blood drawn within required time frames, had at least 1 valid and determinate assay result for the proposed analysis, had received no prohibited vaccines, and had no other major protocol violations.
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End point type |
Secondary
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End point timeframe |
Pre-vaccination to 12 months after the last dose
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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 |
Baseline through 12 months following last dose of Prevenar
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Adverse event reporting additional description |
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. EU BR specific AE tables were generated using latest coding.
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Assessment type |
Systematic | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
15.1
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Reporting groups
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Reporting group title |
Group 1
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Reporting group description |
Subjects 121 to <212 days of age and received 4 doses of Prevenar. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Group 2
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Reporting group description |
Subjects 212 days to <12 months of age (before the first birthday) and received 3 doses of Prevenar. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Group 3
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Reporting group description |
Subjects 12 to <24 months of age (before the second birthday) and received 2 doses of Prevenar. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Group 4
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Reporting group description |
Subjects 24 to <72 months of age (before the sixth birthday) and received 1 dose of Prevenar. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Frequency threshold for reporting non-serious adverse events: 0% | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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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 |