Clinical trial NCT00508742: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pneumococcal Infections
Keywords: Nasopharyngeal Colonization
Streptococcus pneumoniae
Healthy Infants
Vaccines
Pneumococcal Conjugate Vaccine
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2007-07-30
Enrollment: 1866
Sex: ALL
Minimum age (years): 42
Maximum age (years): 98
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: 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
timeFrame: Month 7 through Month 24
Secondary outcomes:
measure: 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
timeFrame: Month 7, 12, 13, 18, 24
Other outcomes:
Locations:
city: Beer-Sheva
country: Israel
facility: Pfizer Investigational Sites (7)
city: Ksaife
country: Israel
facility: Pfizer Investigational Site
city: Rahat A
country: Israel
facility: Pfizer Investigational Site
city: Rahat
country: Israel
facility: Pfizer Investigational Site
city: Segev Shalom
country: Israel
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
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.
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.
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.
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.
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.