Clinical trial NCT00871338: Study to Evaluate GSK Biologicals' GSK2197870A Vaccine Given as Primary Course in Infants
Official title: Study in Healthy Children of GSK Biologicals' DTPa-IPV/Hib-MenC-TT Vaccine, GSK2197870A, Co-administered With Prevenar™ as a Three-dose Primary Vaccination Course in Infancy Followed by a Booster Dose of Menitorix™ at 12 Months of Age
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Neisseria Meningitidis
Haemophilus Influenzae Type b
Keywords: combined
Vaccines
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2009-03-30
Enrollment: 284
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this Phase II study is to evaluate the feasibility of GSK Biologicals' GSK2197870A vaccine co-administered with Wyeth-Lederle's Prevenar™ when given in healthy infants as a three-dose primary vaccination course at 2, 3 and 4 months of age followed by a booster dose of GSK Biologicals' Menitorix™ at 12 months of age.

Detailed description: This protocol posting has been updated following Protocol amendment 1, 11-February-2010; The Study design section is impacted by this amendment.

Eligibility criteria: Inclusion Criteria:

All subjects must satisfy the following criteria at study entry:

* A male or female infant between, and including, 6 and 12 weeks of age at the time of the first vaccination.
* Born after 36 to 42 weeks of gestation.
* Subjects who the investigator believes that their parents/ guardians can and will comply with the requirements of the protocol should be enrolled in the study.
* Written informed consent obtained from the parent or guardian of the subject.
* Healthy subjects as established by medical history and clinical examination before entering into the study.

Exclusion Criteria:

The following criteria should be checked at the time of study entry. If any apply, the subject must not be included in the study:

* Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
* Chronic administration of immunosuppressants or other immune-modifying drugs since birth. For corticosteroids, this will mean prednisone, or equivalent, \>= 0.5 mg/kg/day. Inhaled and topical steroids are allowed.
* Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
* Administration of a vaccine not foreseen by the study protocol within 30 days prior to vaccination, or planned administration during the study period.
* Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product .
* Evidence of previous or intercurrent diphtheria, tetanus, pertussis, poliomyelitis, Hib, pneumococcal and/or group C meningococcal vaccination or disease.
* History of seizures or progressive neurological disease (one episode of febrile convulsion does not constitute an exclusion criterion).
* Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
* History of allergic disease or reactions likely to be exacerbated by any component of the vaccine(s).
* Major congenital defects or serious chronic illness.

The following condition is temporary or self limiting and a subject may be vaccinated once the condition has resolved and no other exclusion criteria are met:

• Current febrile illness or axillary temperature ≥37.5ºC or other moderate to severe illness within 24 hours of study vaccine administration

Primary outcomes:
measure: Number of Seroprotected Subjects for Anti-polyribosylribitol Phosphate (Anti-PRP).
timeFrame: At Month 3
measure: Number of Seropositive Subjects Against Neisseria Meningitidis Using Baby Rabbit Complement (rSBA-MenC)
timeFrame: At Month 2 and Month 3.
Secondary outcomes:
measure: Number of Subjects With Anti-PRP Concentrations Antibody Above the Cut-off.
timeFrame: At Month 3
measure: Number of Subjects With Anti-polysaccharide C (Anti-PSC ) Antibody Concentrations Above the Cut-offs.
timeFrame: At Month 2 and Month 3.
measure: Number of Seroprotected Subjects for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies.
timeFrame: At Month 3.
measure: Number of Seropositive Subjects Against Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN).
timeFrame: At Month 3.
measure: Number of Seroprotected Subjects for Anti-poliovirus (Anti-polio) Types 1, 2 and 3.
timeFrame: At Month 3.
measure: Number of Seropositive Subjects for Anti-pneumococcal (Anti-PNE) Serotypes.
timeFrame: At Month 3
measure: Concentrations for Anti-PRP.
timeFrame: At Month 3.
measure: Titers for rSBA-MenC.
timeFrame: At Month 2 and Month 3.
measure: Concentrations for Anti-PSC.
timeFrame: At Month 2 and Month 3.
measure: Concentrations for Anti-T and Anti-D.
timeFrame: At Month 3.
measure: Concentrations for Anti-PT, Anti-FHA and Anti-PRN.
timeFrame: At Month 3.
measure: Titers for Anti-polio 1, 2 and 3.
timeFrame: At Month 3.
measure: Concentrations for Anti-PNE Serotypes.
timeFrame: At Month 3.
measure: Number of Seroprotected Subjects for Anti-PRP.
timeFrame: At Month 10 and Month 11.
measure: Number of Seropositive Subjects Against rSBA-MenC.
timeFrame: At Month 10 and Month 11.
measure: Number of Subjects With Anti-PSC Antibody Concentrations Above the Cut-offs.
timeFrame: At Month 10 and Month 11.
measure: Number of Seroprotive Subjects for Anti-D and Anti-T Antibodies.
timeFrame: At Month 10.
measure: Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN.
timeFrame: At Month 10.
measure: Number of Seroprotected Subjects for Anti-anti-polio Types 1, 2 and 3.
timeFrame: At Month 10.
measure: Concentrations for Anti-PRP.
timeFrame: At Month 10 and Month 11.
measure: Titers for rSBA-MenC.
timeFrame: At Month 10 and Month 11.
measure: Concentrations for Anti-PSC.
timeFrame: At Month 10 and Month 11.
measure: Concentrations for Anti-T and Anti-D.
timeFrame: At Month 10.
measure: Concentrations for Anti-PT, Anti-FHA and Anti-PRN.
timeFrame: At Month 10.
measure: Titers for Anti-polio 1, 2 and 3.
timeFrame: At Month 10.
measure: Number of Subjects With a Booster Response to rSBA-MenC Antibodies.
timeFrame: At Month 11
measure: Number of Subjects With a Booster Response to Anti-PRP Antibodies.
timeFrame: At Month 11
measure: Number of Subjects With a Booster Response to Anti-PSC Antibodies.
timeFrame: At Month 11
measure: Number of Subjects Reporting Any Solicited Local Symptoms.
timeFrame: During the 8-day (Days 0-7)
measure: Number of Subjects Reporting Any Solicited General Symptoms.
timeFrame: During the 8-day (Days 0-7)
measure: Number of Subjects Reporting Any Unsolicited Adverse Events (AEs).
timeFrame: Within the 31-day (Days 0-30) follow up period after vaccination.
measure: Number of Subjects Reporting Any Serious Adverse Events (SAEs).
timeFrame: During the entire study period (Month 0 to Month 11)
Other outcomes:
Locations:
city: Ely
country: United Kingdom
facility: GSK Investigational Site
state: Cambridgeshire
city: Southampton
country: United Kingdom
facility: GSK Investigational Site
state: Hampshire
city: Oxford
country: United Kingdom
facility: GSK Investigational Site
state: Oxfordshire
city: Bristol
country: United Kingdom
facility: GSK Investigational Site
city: London
country: United Kingdom
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Khatami A, Snape MD, Ohene-Kena B, Young K, Oeser C, Michaelis LJ, Macleod E, Smee H, Van Der Meeren O, Leyssen M, Caubet M, Yu LM, Heath PT, Faust SN, Finn A, Pollard AJ. Phase II study of a three-dose primary vaccination course of DTPa-IPV/Hib-MenC-TT followed by a 12-month Hib-MenC-TT booster in healthy infants. Pediatr Infect Dis J. 2013 Jun;32(6):675-81. doi: 10.1097/INF.0b013e31828672a7.
citation: Khatami A et al. Phase II study of a three-dose primary vaccination course of DTPa-IPV/Hib-MenC-TT followed by a 12-month Hib-MenC-TT booster in healthy infants. Abstract presented at the 7th World Congress World Society for Pediatric Infectious Diseases (WSPID). Melbourne, Australia, 16-19 November 2011.