Safety and Immunogenicity of 10-valent and 13-valent Pneumococcal Conjugate Vaccines in Papua New Guinean Children (PCV1103)

Papua New Guinea Institute of Medical Research

Status and phase: Unknown; Phase 3

Conditions: Meningitis; Otitis Media; Pneumonia; Bacteraemia; Sepsis

Treatments: Biological: Prevenar 13 and Synflorix

Study type: Interventional

Funder types: Other

Identifiers

NCT01619462

PCV1103

Details and patient eligibility

About

The study aims to evaluate the safety and immunogenicity of the 10-valent and 13-valent pneumococcal conjugate vaccines when administered in an accelerated schedule in Papua New Guinean children, who experience early dense upper respiratory tract colonisation with a broad range of pneumococcal serotypes, and to compare antibody titres following a booster dose of polysaccharide vaccine at 9 months with those children who received no booster at the same age.

Full description

The primary aim of the study is to determine whether PCV10 and PCV13 are safe and immunogenic in PNG infants for the serotypes in the respective vaccines. This study is important for the following reasons:

1. There is a lack of data worldwide on immunogenicity in populations with very high early onset of dense URT carriage.
2. The EPI immunisation schedule is very accelerated in PNG (ages 1,2 and 3 months).
3. There are not data on functional antibody to PCVs in PNG.
4. There are no data on NTHi Protein D antibody responses in PNG and worldwide in population with very high URT carriage rates from a young age, i.e. those most likely to benefit from a vaccine including NTHi protein carrier.
5. It is important to investigate impact of vaccine on carriage density in view of our finding of limited impact of 7vPCV on URT carriage.
6. There is no data on antibody responses following 10v or 13v PCV to booster with PPV as young as 9 months of age (which would be the most appropriate within the current PNG EPI schedule and in the many other third world countries).
7. There is no data on antibody responses (including functional assays) to 23vPPV challenge at age 2 years after 23vPPV booster at age 9 months in children primed with PCV.
8. The broad range of serotypes causing IPD in PNG necessitates continuing consideration of 23vPPV as a potential booster at age 9 months.
9. Serotype-specific B cell memory is an important aspect that we can now test to address immunological safety of PPV in children primed with PCV.
10. The Global Alliance for Vaccines and Immunisation (GAVI) and the World Health Organisation (WHO) have committed to the introduction of PCV for infants in GAVI-eligible countries (including PNG) using novel funding mechanism. In PNG, the introduction of a PCV is planned for 2013.

Enrollment: 200 estimated patients

Sex: All

Ages: 28 to 35 days old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Health infants between 28 - 35 days old

Exclusion criteria

• Infants of women not intending to remain in the are for at least two years
• Birth weigh < 2000 g (2kg)
• Severe congenital abnormalities
• Mother or child known to be HIV positive

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

Synflorix or PCV10

Other group

Description:

130 children will receive Synflorix at 1-2-3 months

Treatment:

Biological: Prevenar 13 and Synflorix

Prevenar 13

Other group

Description:

130 children will receive Prevenar 13 at 1-2-3 months

Treatment:

Biological: Prevenar 13 and Synflorix