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

Primary Purpose

Pneumococcal Infections

Status
Completed
Phase
Phase 3
Locations
Israel
Study Type
Interventional
Intervention
13-valent Pneumococcal Conjugate Vaccine
7 valent pneumococcal conjugate vaccine
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pneumococcal Infections focused on measuring Nasopharyngeal Colonization, Streptococcus pneumoniae, Healthy Infants, Vaccines, Pneumococcal Conjugate Vaccine

Eligibility Criteria

42 Days - 98 Days (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Pfizer Investigational Sites (7)
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

13 valent pneumococcal conjugate vaccine

7 valent pneumococcal conjugate vaccine

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
July 26, 2007
Last Updated
May 6, 2013
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00508742
Brief Title
Study Evaluating the Impact of a 13-valent Pneumococcal Conjugate Vaccine on Nasopharyngeal Colonization
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.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
December 2007 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
August 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumococcal Infections
Keywords
Nasopharyngeal Colonization, Streptococcus pneumoniae, Healthy Infants, Vaccines, Pneumococcal Conjugate Vaccine

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1866 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
13 valent pneumococcal conjugate vaccine
Arm Title
2
Arm Type
Active Comparator
Arm Description
7 valent pneumococcal conjugate vaccine
Intervention Type
Biological
Intervention Name(s)
13-valent Pneumococcal Conjugate Vaccine
Other Intervention Name(s)
13vPnC
Intervention Description
1 dose at 2, 4, 6 and 12 months of age
Intervention Type
Biological
Intervention Name(s)
7 valent pneumococcal conjugate vaccine
Other Intervention Name(s)
7vPnC
Intervention Description
1 dose at 2, 4, 6 and 12 months of age
Primary Outcome Measure Information:
Title
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
Description
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.
Time Frame
Month 7 through Month 24
Secondary Outcome Measure Information:
Title
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
Time Frame
Month 7, 12, 13, 18, 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
42 Days
Maximum Age & Unit of Time
98 Days
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Sites (7)
City
Beer-Sheva
ZIP/Postal Code
84101
Country
Israel
Facility Name
Pfizer Investigational Site
City
Ksaife
Country
Israel
Facility Name
Pfizer Investigational Site
City
Rahat A
Country
Israel
Facility Name
Pfizer Investigational Site
City
Rahat
Country
Israel
Facility Name
Pfizer Investigational Site
City
Segev Shalom
Country
Israel

12. IPD Sharing Statement

Citations:
PubMed Identifier
31995183
Citation
Dagan R, Jiang Q, Juergens C, Trammel J, Gruber WC, Scott DA. Carrier-Induced Hyporesponsiveness to Pneumococcal Conjugate Vaccines: Unraveling the Influence of Serotypes, Timing, and Previous Vaccine Dose. Clin Infect Dis. 2021 Feb 1;72(3):448-454. doi: 10.1093/cid/ciaa083.
Results Reference
derived
PubMed Identifier
28087146
Citation
Dagan R, Juergens C, Trammel J, Patterson S, Greenberg D, Givon-Lavi N, Porat N, Gruber WC, Scott DA. PCV13-vaccinated children still carrying PCV13 additional serotypes show similar carriage density to a control group of PCV7-vaccinated children. Vaccine. 2017 Feb 7;35(6):945-950. doi: 10.1016/j.vaccine.2016.12.052. Epub 2017 Jan 11.
Results Reference
derived
PubMed Identifier
27422342
Citation
Dagan R, Juergens C, Trammel J, Patterson S, Greenberg D, Givon-Lavi N, Porat N, Gruber WC, Scott DA. Modeling pneumococcal nasopharyngeal acquisition as a function of anticapsular serum antibody concentrations after pneumococcal conjugate vaccine administration. Vaccine. 2016 Aug 5;34(36):4313-20. doi: 10.1016/j.vaccine.2016.06.075. Epub 2016 Jul 12.
Results Reference
derived
PubMed Identifier
25355940
Citation
Dagan R, Juergens C, Trammel J, Patterson S, Greenberg D, Givon-Lavi N, Porat N, Gurtman A, Gruber WC, Scott DA. Efficacy of 13-valent pneumococcal conjugate vaccine (PCV13) versus that of 7-valent PCV (PCV7) against nasopharyngeal colonization of antibiotic-nonsusceptible Streptococcus pneumoniae. J Infect Dis. 2015 Apr 1;211(7):1144-53. doi: 10.1093/infdis/jiu576. Epub 2014 Oct 29.
Results Reference
derived
PubMed Identifier
23804191
Citation
Dagan R, Patterson S, Juergens C, Greenberg D, Givon-Lavi N, Porat N, Gurtman A, Gruber WC, Scott DA. Comparative immunogenicity and efficacy of 13-valent and 7-valent pneumococcal conjugate vaccines in reducing nasopharyngeal colonization: a randomized double-blind trial. Clin Infect Dis. 2013 Oct;57(7):952-62. doi: 10.1093/cid/cit428. Epub 2013 Jun 26.
Results Reference
derived
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=6096A1-3006&StudyName=Study%20Evaluating%20the%20Impact%20of%20a%2013-valent%20Pneumococcal%20Conjugate%20Vaccine%20on%20Nasopharyngeal%20Colonization
Description
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Study Evaluating the Impact of a 13-valent Pneumococcal Conjugate Vaccine on Nasopharyngeal Colonization

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