Alternative vaccination schedules with pneumococcal polysaccharide/protein conjugate vaccine: immunogenicity of the prime-booster approach among Gambian infants

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN50377687

Enrollment

675

Registered

2004-09-22

Start date

2005-05-01

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pneumococcus/vaccines Infections and Infestations Vaccination

Interventions

Group 1: Infants here will receive their only dose of a 7-valent pneumococcal conjugate vaccine at 6 weeks of life and a dose of polysaccharide vaccine at 9 months. Group 2: A dose of conjugate vaccin

Eligibility

Inclusion criteria

Inclusion criteria: Babies will be recruited when they present for first dose of Diphtheria, Pertussis, Tetanus (DPT)-Haemophilus influenzae type b (Hib) vaccine and written informed consent obtained at that time

Exclusion criteria

Exclusion criteria: 1. Babies born to known human immunodeficiency virus (HIV) positive mothers 2. Those with neurological abnormality 3. No parental consent 4. Established pneumococcal disease

Design outcomes

Primary

Measure	Time frame
1. Immunogenicity of 7-valent pneumococcal conjugate vaccine at ages 18 weeks and 11 months after one, two and three doses of conjugate vaccines, measuring for antibody concentrations greater than or equal to 0.35 ug/ml 2. Secondary immune response (antibody) to pnuemococcal polysaccharide vaccine at age 11 months after one, two or three doses of 7-valent conjugate vaccine (antibody concentrations greater than or equal to 0.35 ug/ml)	—

Measure

Time frame

1. Immunogenicity of 7-valent pneumococcal conjugate vaccine at ages 18 weeks and 11 months after one, two and three doses of conjugate vaccines, measuring for antibody concentrations greater than or equal to 0.35 ug/ml 2. Secondary immune response (antibody) to pnuemococcal polysaccharide vaccine at age 11 months after one, two or three doses of 7-valent conjugate vaccine (antibody concentrations greater than or equal to 0.35 ug/ml)

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Secondary

Measure	Time frame
1. Persistence of antibody at age 15 months of age 2. Evidence of memory response following Conjugate vaccines using assays of antibody avidity and affinity 3. Naso-pharyngeal carriage of vaccine and non-vaccine serotypes at ages 18 weeks, 11 and 15 months of age 4. Monitoring for safety and local reaction up to 15 months of age. Two main aspects of the safety surveillance will be analysed: 4.1. Serious Adverse Events (SAE) 4.2. Local and Systemic reactions Antibody concentrations to serotypes covered by the 7-valent conjugate vaccine (4, 6B, 9V, 14, 18C, 19F, and 23F) as well as antibody concentration to selected serotypes covered by the polysaccharide vaccine (1, 3, 5 and 12) will be measured.	—

Measure

Time frame

1. Persistence of antibody at age 15 months of age 2. Evidence of memory response following Conjugate vaccines using assays of antibody avidity and affinity 3. Naso-pharyngeal carriage of vaccine and non-vaccine serotypes at ages 18 weeks, 11 and 15 months of age 4. Monitoring for safety and local reaction up to 15 months of age. Two main aspects of the safety surveillance will be analysed: 4.1. Serious Adverse Events (SAE) 4.2. Local and Systemic reactions Antibody concentrations to serotypes covered by the 7-valent conjugate vaccine (4, 6B, 9V, 14, 18C, 19F, and 23F) as well as antibody concentration to selected serotypes covered by the polysaccharide vaccine (1, 3, 5 and 12) will be measured.

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Countries

Gambia

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026