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

Pneumococcal Infections Clinical Trial

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.

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

• Pneumococcal Infections

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

External Links

•   To obtain contact information for a study center near you, click here.