Study Evaluating the Impact of a 13-valent Pneumococcal Conjugate Vaccine on Nasopharyngeal Colonization

Study Overview
=================
Brief Summary
-----------------
This study is designed to assess the impact of 13-valent Pneumococcal Conjugate Vaccine (13vPnC) on nasopharyngeal colonization with Streptococcus pneumoniae in healthy infants.

Official Title
-----------------
A Phase 3, Randomized, Active-Controlled, Double-blind Trial Evaluating the Impact of a 13-valent Pneumococcal Conjugate Vaccine on Nasopharyngeal Colonization With Vaccine Serotypes of Streptococcus Pneumoniae in Healthy Infants in Israel.

Conditions
-----------------
Pneumococcal Infections

Intervention / Treatment
-----------------
* Biological: 13-valent Pneumococcal Conjugate Vaccine
* Biological: 7 valent pneumococcal conjugate vaccine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy infants aged 2 months (42-98 days) at time of enrolment. Available for the entire study period and whose parent/legal guardian can be reached by telephone. Exclusion Criteria: Previous vaccination with licensed or investigational pneumococcal vaccine. A previous anaphylactic reaction to any vaccine or vaccine-related component. Contraindication to vaccination with a pneumococcal conjugate vaccine.

Ages Eligible for Study
-----------------
Minimum Age: 42 Days
Maximum Age: 98 Days

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>13 valent pneumococcal conjugate vaccine | Biological: 13-valent Pneumococcal Conjugate Vaccine<br>* 1 dose at 2, 4, 6 and 12 months of age<br>* Other names: 13vPnC;|
| Active Comparator: 2<br>7 valent pneumococcal conjugate vaccine | Biological: 7 valent pneumococcal conjugate vaccine<br>* 1 dose at 2, 4, 6 and 12 months of age<br>* Other names: 7vPnC;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With a New Acquisition of Serotype 6A' (6A + 6C) or 19A Combined 1 Month After the Infant Series to 24 Months of Age | A new acquisition was defined as the detection of a serotype (here 6A' [6A + 6C] or 19A), once a participant was fully vaccinated (one month after dose 3), that had not been detected previously in the baseline samples at 2, 4, 6 months of age. | Month 7 through Month 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Nasopharyngeal Cultures Testing Positive for 6A' (6A + 6C) or 19A Serotypes of Streptococcus Pneumoniae (S. Pneumoniae) at 7, 12, 13, 18 and 24 Months of Age |  | Month 7, 12, 13, 18, 24 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Nasopharyngeal Colonization, Streptococcus pneumoniae, Healthy Infants, Vaccines, Pneumococcal Conjugate Vaccine