Pneumococcal vaccine schedules acquisition, immunogenicity, and pneumococcal conjugate and yellow fever vaccine co-administration study

The effect of a two-dose compared to a three-dose schedule of pneumococcal conjugate vaccine on pneumococcal acquisition, immunogenicity, and co-administration of pneumococcal conjugate and yellow fever vaccines

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN72821613

Enrollment

784

Registered

2019-11-28

Start date

2020-09-14

Completion date

Unknown

Last updated

2025-01-28

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

Conditions

Pneumococcal acquisition and vaccine immunogenicity Infections and Infestations

Interventions

13-valent pneumococcal conjugate vaccine (PCV13) is a licenced product, procured by the Gambia Government EPI, delivered in two schedules, one with doses scheduled at ages 6, 10 and 14 weeks (3+0 sche

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Resident in the study area (PVS-AcqImm trial) 2. Age 0-6 weeks 3. Intention to reside in cluster until 18 months of age

Exclusion criteria

Exclusion criteria: 1. Intent to move out of the study area before 18 months of age 2. Age greater than 6 weeks 3. Prematurity <34 weeks gestation 4. Birth weight <2.0kg or weight <2.5 kg 5. History of invasive bacterial infection or measles 6. Receiving long-term antibiotic therapy, defined as greater than 4 weeks 7. HIV infection in the infant or mother 8. Chronic debilitating illness 9. Immunosuppressive therapy or immunodeficiency disorder 10. Contraindication to PCV13 – severe hypersensitivity to a previous dose of PCV13 11. Contraindication to YF vaccine

Design outcomes

Primary

Measure	Time frame
1. Nasopharyngeal acquisition of vaccine-type pneumococci measured using latex sweep serotyping at five timepoints between 9 and 14 months of age 2. Concentration of pneumococcal vaccine-type serotype-specific IgG measured by enzyme-linked immunosorbent assay at 18 months of age 3. Yellow fever neutralizing antibody titre expressed as the serum dilution that yields neutralisation of greater than or equal to 50% of virus infections of a standard cell line, measured 1 month after administration of yellow fever vaccine	—

Measure

Time frame

1. Nasopharyngeal acquisition of vaccine-type pneumococci measured using latex sweep serotyping at five timepoints between 9 and 14 months of age 2. Concentration of pneumococcal vaccine-type serotype-specific IgG measured by enzyme-linked immunosorbent assay at 18 months of age 3. Yellow fever neutralizing antibody titre expressed as the serum dilution that yields neutralisation of greater than or equal to 50% of virus infections of a standard cell line, measured 1 month after administration of yellow fever vaccine

—

Secondary

Measure	Time frame
1. Rate of non-vaccine type pneumococcal nasopharyngeal acquisition between 9 and 14 months of age 2. Proportion with vaccine-type pneumococcal colonisation at 6, 9 and 18 months of age 3. Proportion with geometric mean concentration of pneumococcal vaccine-type serotype-specific IgG =0.35 µg/ml, 4 weeks after the primary series and 4 weeks after the booster dose at age 9 months, and at 18 months of age 4. Pneumococcal vaccine-type opsonophagocytic antibody titres following a single dose of PCV13 at age 6 weeks, following three primary doses, following the booster dose at age 9 months, and at 18 months of age 5. Geometric mean concentrations of pneumococcal vaccine-type serotype-specific IgG 4 weeks after administration of PCV13 at 9 months of age with and without co-administration with yellow fever vaccine	—

Measure

Time frame

1. Rate of non-vaccine type pneumococcal nasopharyngeal acquisition between 9 and 14 months of age 2. Proportion with vaccine-type pneumococcal colonisation at 6, 9 and 18 months of age 3. Proportion with geometric mean concentration of pneumococcal vaccine-type serotype-specific IgG =0.35 µg/ml, 4 weeks after the primary series and 4 weeks after the booster dose at age 9 months, and at 18 months of age 4. Pneumococcal vaccine-type opsonophagocytic antibody titres following a single dose of PCV13 at age 6 weeks, following three primary doses, following the booster dose at age 9 months, and at 18 months of age 5. Geometric mean concentrations of pneumococcal vaccine-type serotype-specific IgG 4 weeks after administration of PCV13 at 9 months of age with and without co-administration with yellow fever vaccine

—

Countries

Gambia

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 8, 2026