NCT00508742

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,866

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Dec 2007

Typical duration for phase_3

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 26, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 30, 2007

Completed
4 months until next milestone

Study Start

First participant enrolled

December 1, 2007

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
12 months until next milestone

Results Posted

Study results publicly available

July 13, 2012

Completed
Last Updated

May 10, 2013

Status Verified

May 1, 2013

Enrollment Period

3.7 years

First QC Date

July 26, 2007

Results QC Date

June 12, 2012

Last Update Submit

May 6, 2013

Conditions

Pneumococcal Infections

Keywords

Nasopharyngeal ColonizationStreptococcus pneumoniaeHealthy InfantsVaccinesPneumococcal Conjugate Vaccine

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • 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

Study Arms (2)

1

EXPERIMENTAL

13 valent pneumococcal conjugate vaccine

Biological: 13-valent Pneumococcal Conjugate Vaccine

2

ACTIVE COMPARATOR

7 valent pneumococcal conjugate vaccine

Biological: 7 valent pneumococcal conjugate vaccine

Interventions

13-valent Pneumococcal Conjugate VaccineBIOLOGICAL

1 dose at 2, 4, 6 and 12 months of age

Also known as: 13vPnC
1
7 valent pneumococcal conjugate vaccineBIOLOGICAL

1 dose at 2, 4, 6 and 12 months of age

Also known as: 7vPnC
2

Eligibility Criteria

Age42 Days - 98 Days
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Pfizer Investigational Sites (7)

Beersheba, Beer-Sheva, 84101, Israel

Location

Pfizer Investigational Site

Shaqib al-Salam, Segev Shalom, Israel

Location

Pfizer Investigational Site

Ksaife, Israel

Location

Pfizer Investigational Site

Rahat, Israel

Location

Pfizer Investigational Site

Rahat A, Israel

Location

Related Publications (5)

  • 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.

    PMID: 31995183DERIVED

  • 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.

    PMID: 28087146DERIVED

  • 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.

    PMID: 27422342DERIVED

  • 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.

    PMID: 25355940DERIVED

  • 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.

    PMID: 23804191DERIVED

Related Links

MeSH Terms

Conditions

Pneumococcal Infections

Interventions

Heptavalent Pneumococcal Conjugate Vaccine

Condition Hierarchy (Ancestors)

Streptococcal InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Intervention Hierarchy (Ancestors)

Pneumococcal VaccinesStreptococcal VaccinesBacterial VaccinesVaccinesBiological ProductsComplex MixturesVaccines, Combined

Limitations and Caveats

Study designated analysis of effect of 13vPnC on serotypes 6A+19A, changed prior to unblinding, to effect on 6A'+19A. Serotype 6A found to include serotype 6A isolates and isolates of newly identified serotype 6C. Serotype 6A assessed as 6A+6C (6A').

Results Point of Contact

Title
Pfizer ClinicalTrials.gov Call Center
Organization
Pfizer, Inc.
ClinicalTrials.gov_Inquiries@pfizer.com
1-800-718-1021

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 26, 2007

First Posted

July 30, 2007

Study Start

December 1, 2007

Primary Completion

August 1, 2011

Study Completion

August 1, 2011

Last Updated

May 10, 2013

Results First Posted

July 13, 2012

Record last verified: 2013-05

Locations

IL(5)