Clinical trial NCT00814710: Primary Vaccination Study With a Pneumococcal Conjugate Vaccine in Healthy Children 6 to 10 Weeks of Age
Official title: Primary Vaccination Course in Healthy Children Receiving the Pneumococcal Vaccine GSK 1024850A Co-administered With Tritanrix™-HepB/Hib at 6, 10 and 14 Weeks of Age
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Infections, Streptococcal
Streptococcus Pneumoniae
Keywords: Pneumococcal disease
Pneumococcal vaccine
Safety
Primary vaccination
Immunogenicity
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2008-12-25
Enrollment: 360
Sex: ALL
Minimum age (years): 6
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to assess the immunogenicity in terms of antibody response and the safety/reactogenicity in terms of solicited and unsolicited symptoms and serious adverse events following primary vaccination of Indian infants with pneumococcal conjugate vaccine GSK1024850A co-administered with a diphtheria, tetanus, whole cell pertussis (DTPw)-combined vaccine during the first 4 months of life. The study will be conducted in India.


Eligibility criteria: Inclusion Criteria:

* Male or female subjects between, and including 6-10 weeks of age at the time of the first vaccination.
* Subjects for whom the investigator believes that their parent(s)/guardian(s) can and will comply with the requirements of the protocol.
* Written or oral, signed or thumb-printed informed consent obtained from the parent(s)/guardian(s) of the child/ward. Where parent(s)/guardian(s) are illiterate, the consent form will be countersigned by a witness.
* Free of any known or suspected health problems (as established by medical history and clinical examination before entering into the study).

Exclusion Criteria:

* Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the first dose of the study vaccines, or planned use 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 (pharmaceutical product or device).
* Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs since birth.
* A family history of congenital or hereditary immunodeficiency.
* Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination.
* Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period (with the exception of hepatitis B immunoglobulins at birth).
* Previous vaccination against diphtheria, tetanus, pertussis, hepatitis B, Haemophilus influenzae type b and/or Streptococcus pneumoniae (with the exception of hepatitis B vaccination at birth or at least 30 days before the subject's first study visit).
* History of, or intercurrent, diphtheria, tetanus, pertussis, hepatitis B, Streptococcus and Haemophilus influenzae type b disease.
* History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
* History of any neurological disorders or seizures.
* Major congenital defects or serious chronic illness.
* Acute disease at the time of enrolment.
* Babies for which birth weight is \< 2 kilogram.

Primary outcomes:
measure: Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes
timeFrame: One month after primary immunization (month 3)
measure: Concentration of Antibody Against Protein D (PD)
timeFrame: One month after primary immunization (month 3)
Secondary outcomes:
measure: Number of Subjects With Opsonophagocytic Activity Against Pneumococcal Serotypes
timeFrame: One month after primary immunization (month 3)
measure: Number of Subjects With Antibody Concentrations Against Pneumococcal Serotypes Equal to or Above Cut-off Value
timeFrame: One month after primary immunization
measure: Concentrations of Antibodies Against Pneumococcal Cross-reactive Serotypes
timeFrame: One month after primary immunization (month 3)
measure: Number of Subjects Seropositive for Pneumococcal Serotypes
timeFrame: One month after primary immunization (month 3)
measure: Number of Subjects Seropositive for Protein D (PD)
timeFrame: One month after primary immunization (month 3)
measure: Concentration of Antibody Against Polyribosyl-ribitol Phosphate (PRP)
timeFrame: One month after primary immunization (month 3)
measure: Concentration of Antibodies Against Diphteria (Anti-DT) and Tetanus (Anti-TT)
timeFrame: One month after primary immunization (month 3)
measure: Concentration of Antibody Against Bordetella Pertussis (B. Pertussis)
timeFrame: One month after primary immunization (month 3)
measure: Concentration of Antibody Against Hepatitis B (Anti-HBs) by Enzyme-Linked ImmunoSorbent Assay (ELISA).
timeFrame: One month after primary immunization (month 3)
measure: Number of Subjects Seropostive for B. Pertussis
timeFrame: One month after primary immunization (month 3)
measure: Number of Seroprotected Subjects (Anti-DT, Anti-TT, Anti-PRP, Anti-HBs)
timeFrame: One month after primary immunization (month 3)
measure: Number of Seroprotected Subjects (Anti-PRP Above the Cut-off of 1.0 µg/mL)
timeFrame: One month after primary immunization (month 3)
measure: Number of Subjects With Solicited Local and General Symptoms
timeFrame: Within 4 days (day 0-3) after vaccination
measure: Number of Subjects With Unsolicited Adverse Events (AEs)
timeFrame: Within 31 days (day 0-30) after vaccination
measure: Number of Subjects With Serious Adverse Events (SAEs)
timeFrame: Following first vaccination (Month 0) throughout the entire study period (month 3)
Other outcomes:
Locations:
city: Kolkata
country: India
facility: GSK Investigational Site
city: Ludhiana
country: India
facility: GSK Investigational Site
city: Pune
country: India
facility: GSK Investigational Site
city: Vellore
country: India
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Lalwani S, Chatterjee S, Chhatwal J, Verghese VP, Mehta S, Shafi F, Borys D, Moreira M, Schuerman L. Immunogenicity, safety, and reactogenicity of the 10-valent pneumococcal non-typeable Hemophilus influenzae protein D conjugate vaccine (PHiD-CV) when co-administered with the DTPw-HBV/Hib vaccine in Indian infants: a single-blind, randomized, controlled study. Hum Vaccin Immunother. 2012 May;8(5):612-22. doi: 10.4161/hv.19287. Epub 2012 May 1.
citation: Lalwani S, Chatterjee S, Chhatwal J, Simon A, Ravula S, Francois N, Mehta S, Strezova A, Borys D. Randomized, open-label study of the impact of age on booster responses to the 10-valent pneumococcal nontypeable Haemophilus influenzae protein D conjugate vaccine in children in India. Clin Vaccine Immunol. 2014 Sep;21(9):1292-300. doi: 10.1128/CVI.00068-14. Epub 2014 Jul 9.