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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00508742
Other study ID # 6096A1-3006
Secondary ID B1851007
Status Completed
Phase Phase 3
First received July 26, 2007
Last updated May 6, 2013
Start date December 2007
Est. completion date August 2011

Study information

Verified date May 2013
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 1866
Est. completion date August 2011
Est. primary completion date August 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 42 Days to 98 Days
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Biological:
13-valent Pneumococcal Conjugate Vaccine
1 dose at 2, 4, 6 and 12 months of age
7 valent pneumococcal conjugate vaccine
1 dose at 2, 4, 6 and 12 months of age

Locations

Country Name City State
Israel Pfizer Investigational Sites (7) Beer-Sheva
Israel Pfizer Investigational Site Ksaife
Israel Pfizer Investigational Site Rahat
Israel Pfizer Investigational Site Rahat A
Israel Pfizer Investigational Site Segev Shalom

Sponsors (1)

Lead Sponsor Collaborator
Pfizer

Country where clinical trial is conducted

Israel, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
Secondary 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 No
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