Phase 3
Completed N=360
Primary Vaccination Study With a Pneumococcal Conjugate Vaccine in Healthy Children 6 to 10 Weeks of Age
Infections, Streptococcal · Streptococcus Pneumoniae
Source: ClinicalTrials.gov NCT00814710 ↗
Enrolled (actual)
360
Serious AEs
1.7%
Results posted
Oct 2010
Primary outcomePrimary: Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes — 3.27; 0.03; 3.80; 0.04 µg/mL
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes |
3.27; 0.03; 3.80; 0.04; 4.17; 0.05 | — |
| PRIMARY Concentration of Antibody Against Protein D (PD) |
2981.7; 63.9 | — |
| SECONDARY Number of Subjects With Opsonophagocytic Activity Against Pneumococcal Serotypes |
105; 3; 114; 24; 111; 2 | — |
| SECONDARY Number of Subjects With Antibody Concentrations Against Pneumococcal Serotypes Equal to or Above Cut-off Value |
228; 2; 225; 10; 226; 10 | — |
| SECONDARY Concentrations of Antibodies Against Pneumococcal Cross-reactive Serotypes |
0.15; 0.06; 0.33; 0.08 | — |
| SECONDARY Number of Subjects Seropositive for Pneumococcal Serotypes |
228; 19; 228; 24; 229; 46 | — |
| SECONDARY Number of Subjects Seropositive for Protein D (PD) |
226; 16 | — |
| SECONDARY Concentration of Antibody Against Polyribosyl-ribitol Phosphate (PRP) |
31.367; 34.415 | — |
| SECONDARY Concentration of Antibodies Against Diphteria (Anti-DT) and Tetanus (Anti-TT) |
2.580; 2.065; 3.726; 1.542 | — |
| SECONDARY Concentration of Antibody Against Bordetella Pertussis (B. Pertussis) |
90.3; 114.5 | — |
| SECONDARY Concentration of Antibody Against Hepatitis B (Anti-HBs) by Enzyme-Linked ImmunoSorbent Assay (ELISA). |
1970.5; 1378.2 | — |
| SECONDARY Number of Subjects Seropostive for B. Pertussis |
113; 116 | — |
| SECONDARY Number of Seroprotected Subjects (Anti-DT, Anti-TT, Anti-PRP, Anti-HBs) |
113; 116; 113; 116; 113; 115 | — |
| SECONDARY Number of Seroprotected Subjects (Anti-PRP Above the Cut-off of 1.0 µg/mL) |
113; 114 | — |
| SECONDARY Number of Subjects With Solicited Local and General Symptoms |
209; 105; 128; 76; 166; 83 | — |
| SECONDARY Number of Subjects With Unsolicited Adverse Events (AEs) |
38; 17 | — |
| SECONDARY Number of Subjects With Serious Adverse Events (SAEs) |
5; 1 | — |
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.
Data sourced from ClinicalTrials.gov (NCT00814710). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.