A trial to evaluate the safety and reactogenicity of an investigational pneumococcal vaccine in infants receiving 3-dose primary dosing series followed by a booster dose at 12 to 15 months of age

A phase 1, observer-blind, randomised, active controlled trial to evaluate the safety and reactogenicity of an investigational pneumococcal vaccine in infants receiving 3-dose primary dosing series followed by a booster dose at 12 to 15 months of age

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

PACTR

Registry ID

PACTR202605824103374

Enrollment

Registered

2026-05-15

Start date

2026-07-10

Completion date

Unknown

Last updated

2026-06-22

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

Conditions

Paediatrics

Interventions

Pn MAPS30plus

Prevenar

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Participants will be included in the study if they: • Are infants between 42 to 90 days of age (about 2 months old). • Are full term infants, which means the pregnancy lasted between 37 to 42 completed weeks. • Weighed more than 2.5 kilograms at the time of birth. • Are healthy infants as determined by the study doctor.

Exclusion criteria

Exclusion criteria: Participants will be excluded from the study if they: • Have a history of a serious allergic reaction to any component of the study vaccine. • Have previously been vaccinated against pneumococcal disease or have had a confirmed serious pneumococcal infection. • Have a condition that weakens their immune system, which is the body's natural resistance against illness. • Are participating in another clinical study or have recently used any other investigational product.

Design outcomes

Primary

Measure	Time frame
• Occurrence of any side effects at the injection site and overall body, within 7 days after the treatment. • Occurrence of any unexpected or untoward medical problems called Adverse Events (AEs), that are generally unexpected within 30 days after study treatment administration referred to as unsolicited AEs. • Occurrence of Serious AEs (SAEs), AEs of Special Interest (AESIs) and side effects that are so severe which can cause the participant to stop the treatment during the study period.	—

Measure

Time frame

• Occurrence of any side effects at the injection site and overall body, within 7 days after the treatment. • Occurrence of any unexpected or untoward medical problems called Adverse Events (AEs), that are generally unexpected within 30 days after study treatment administration referred to as unsolicited AEs. • Occurrence of Serious AEs (SAEs), AEs of Special Interest (AESIs) and side effects that are so severe which can cause the participant to stop the treatment during the study period.

—

Countries

South Africa

Contacts

Public ContactItumeleng Siweya

Clinical Operations Director. GMASE Head Clinical Operations South Africa

itumeleng.i.siweya@gsk.com+27103001000

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Jun 29, 2026