Phase 3 Completed N=238 Randomized Prevention

Immunological Persistence After Priming With GSK1024850A Vaccine and Safety& Immunogenicity After Booster Dose

Infections, Streptococcal

Source: ClinicalTrials.gov NCT01119625 ↗

Enrolled (actual)

238

Serious AEs

1.7%

Results posted

Mar 2012

Primary outcomePrimary: Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes. — 0.48; 0.35; 0.56; 0.48 µg/mL

Summary

This primary purpose of this study is the evaluation of the immunological persistence following completion of the 3-dose primary vaccination course with either a clinical or a commercial lot of pneumococcal conjugate vaccine GSK1024850A in study NCT00808444. In addition, the study will also assess the safety, reactogenicity and immunogenicity of a fourth dose of pneumococcal conjugate vaccine GSK1024850A (commercial lot) when co-administered with Infanrix-IPV/Hib at 18-21 months of age in children primed in study NCT00808444. The primary vaccination study was conducted in Malaysia and Singapore. The booster vaccination study will not be performed in Malaysia since the pneumococcal conjugate vaccine GSK1024850A has been registered in September 2009. However, subjects in Malaysia will be offered a booster dose of the commercial pneumococcal conjugate vaccine licensed in Malaysia and Infanrix-IPV/Hib vaccine during the second year of life according to the nationally recommended regimen. Administration of the booster dose will be outside the set-up of a clinical trial. Hence no data will be collected, no blood samples will be taken in Malaysia.

Outcome Measures

Outcome	Result	p-value
PRIMARY Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes.	0.48; 0.35; 7.14; 6.29; 0.56; 0.48	—
PRIMARY Concentrations of Antibodies Against Protein D (PD).	794.9; 618.4; 3631.3; 3115.9	—
SECONDARY Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs).	61; 70; 8; 13; 66; 61	—
SECONDARY Number of Subjects Reporting Any, Grade 3 and Related Solicited General Adverse Events (AEs).	38; 49; 2; 2; 38; 48	—
SECONDARY Number of Subjects Reporting Unsolicited Adverse Events (AEs).	18; 25	—
SECONDARY Number of Subjects Reporting Serious Adverse Events (SAEs).	0; 4	—
SECONDARY Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes.	—	—
SECONDARY Opsonophagocytic Activity Against Cross-reactive Pneumococcal Serotypes 6A and 19A.	—	—
SECONDARY Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes.	0.23; 0.21; 2.13; 1.99; 0.18; 0.20	—
SECONDARY Concentrations of Antibodies Against Diphtheria and Tetanus.	0.31; 0.29; 8.17; 10.89; 0.52; 0.46	—
SECONDARY Concentrations of Antibodies Against Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN).	5.8; 6.8; 80.8; 86.0; 19.3; 29.6	—
SECONDARY Concentrations of Antibodies Against Polyribosyl-ribitol Phosphate (PRP).	0.66; 0.84; 58.26; 49.36	—
SECONDARY Titers of Antibodies Against Poliovirus Types 1, 2 and 3.	44.2; 32.8; 982.2; 985.2; 38.0; 34.9	—
SECONDARY Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes.	0.48; 0.35; 7.14; 6.29; 0.56; 0.48	—
SECONDARY Concentrations of Antibodies Against Protein D (PD).	794.9; 618.4; 3631.3; 3115.9	—

Eligibility Criteria

Inclusion Criteria

Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) (LAR) can and will comply with the requirements of the protocol
Male or female between, and including, 18 and 21 months of age at the time of booster vaccination.
Subjects who received three doses of pneumococcal conjugate vaccine in study NCT00808444
Written informed consent obtained from the parents/LAR(s) of the subject.
Healthy subjects as established by medical history and clinical examination before entering into the study.

Exclusion Criteria

Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding vaccination, 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.
Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to vaccination.
A family history of congenital or hereditary immunodeficiency.
Administration of immunoglobulins and/ or any blood products within the 3 months preceding vaccination or planned use during the study period.
Administration of any pneumococcal and/or vaccine containing diphtheria, tetanus, pertussis, poliomyelitis or Haemophilus influenzae type b antigens since the end of study NCT00808444.
Planned administration/administration of a vaccine not foreseen by the study protocol during the study period starting from 30 days before vaccination and ending 30 days after vaccination.
Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
History of any reaction or allergic disease likely to be exacerbated by any component of the study vaccines.
Known hypersensitivity to any component of the study vaccines including anaphylactic reactions following the administration of the study vaccines.
Major congenital defects or serious chronic illness.
History of any neurologic disorders or seizures. (Subjects who have had a single uncomplicated febrile convulsion in the past can be included)
Fever at the time of vaccination.
Fever is defined as rectal temperature >= 38.0°C or tympanic/axillary/ oral temperature >= 37.5°C.
Acute disease at the time of enrolment.
Subjects with a minor illness without fever may be enrolled at the discretion of the investigator.
Child in care.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01119625). 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.