Last updated: 07/17/2024 15:17:50
Primary Vaccination Study with a Pneumococcal Conjugate Vaccine in Healthy Children 6 to 10 weeks of Age
EudraCT ID
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
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
Trial description: 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.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
Single (Participant)
Allocation:
Randomized
Primary outcomes:
Concentrations of antibodies against vaccine pneumococcal serotypes
Timeframe: One month after primary immunization (month 3)
Concentration of antibody against protein D (PD)
Timeframe: One month after primary immunization (month 3)
Secondary outcomes:
Number of subjects with opsonophagocytic activity against pneumococcal serotypes
Timeframe: One month after primary immunization (month 3)
Number of subjects with antibody concentrations against pneumococcal serotypes equal to or above cut-off value
Timeframe: One month after primary immunization
Concentrations of antibodies against pneumococcal cross-reactive serotypes
Timeframe: One month after primary immunization (month 3)
Number of subjects seropositive for pneumococcal serotypes
Timeframe: One month after primary immunization (month 3)
Number of subjects seropositive for protein D (PD)
Timeframe: One month after primary immunization (month 3)
Concentration of antibody against polyribosyl-ribitol phosphate (PRP)
Timeframe: One month after primary immunization (month 3)
Concentration of antibodies against diphteria (anti-DT) and tetanus (anti-TT)
Timeframe: One month after primary immunization (month 3)
Concentration of antibody against Bordetella pertussis (B. pertussis)
Timeframe: One month after primary immunization (month 3)
Concentration of antibody against hepatitis B (anti-HBs) by Enzyme-Linked ImmunoSorbent Assay (ELISA).
Timeframe: One month after primary immunization (month 3)
Number of subjects seropostive for B. pertussis
Timeframe: One month after primary immunization (month 3)
Number of seroprotected subjects (anti-DT, anti-TT, anti-PRP, anti-HBs)
Timeframe: One month after primary immunization (month 3)
Number of seroprotected subjects (anti-PRP above the cut-off of 1.0 µg/mL)
Timeframe: One month after primary immunization (month 3)
Number of subjects with solicited local and general symptoms
Timeframe: Within 4 days (day 0-3) after vaccination
Number of subjects with unsolicited adverse events (AEs)
Timeframe: Within 31 days (day 0-30) after vaccination
Number of subjects with serious adverse events (SAEs)
Timeframe: Following first vaccination (Month 0) throughout the entire study period (month 3)
Interventions:
Enrollment:
360
Primary completion date:
2009-13-11
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Lalwani S et al. (2012) Immunogenicity, safety and reactogenicity of the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) when co-administered with the DTPw-HBV/Hib vaccine in Indian infants: a single-blind, randomised, controlled study. Hum Vaccin Immunother. 8(5):613-623.
Medical condition
Infections, Streptococcal
Product
GSK1024850A
Collaborators
Not applicable
Study date(s)
March 2009 to November 2009
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
6 - 10 weeks
Accepts healthy volunteers
Yes
- 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.
- 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).
Inclusion and exclusion criteria
Inclusion criteria:
- 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).
Male or female subjects between, and including 6-10 weeks of age at the time of the first vaccination.
Exclusion criteria:
- 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.
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.
Trial location(s)
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Study complete
Actual primary completion date
2009-13-11
Actual study completion date
2009-13-11
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
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