Pneumococcal Conjugate Vaccine Followup (PCVFU)

William Pomat

Status and phase: Completed; Phase 2

Conditions: Immune Tolerance

Treatments: Biological: Prevenar + PPV; Biological: No Prevenar + PPV at 9 months; Biological: Infant PCV (Prevenar) + PPV at 9 months; Biological: Control

Study type: Interventional

Funder types: Other

Identifiers

NCT01414504

PCVFU927

Details and patient eligibility

About

Recently, controversy has emerged regarding the role of the 23vPPV in infants due to potential immunological hypo-responsiveness (i.e. a poorer immune response to repeat vaccination). Although previous experience of 23vPPV in children in PNG has demonstrated protective efficacy against acute lower respiratory tract infection, the investigators feel it is a matter of urgency to determine if 23vPPV administration provides elevated antibody concentrations at 3 to 5 years of age, and to ensure the immunological safety of the 23vPPV in infants.

Following consent and eligibility assessment, a baseline blood sample and nose swab will be taken, a 0.1ml dose of 23vPPV will be administered and a follow up blood sample and nose swab will be collected 28 days later. The investigators will also collect data on incidence of ALRI in all study participants by medical record review.

Enrollment: 280 patients

Sex: All

Ages: 3 to 5 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• PNG Infants aged 3 to 5 yrs of age who participated in previous PNG Neonatal PCV study and received PPV between 9 and 12 months of age, or age- and sex-matched controls who live in the same villages or urban area
• Informed parental/guardian consent

Exclusion criteria

• Known HIV infection or other immunosuppressive condition or treatment.
• Prior receipt of 2 doses of pneumococcal polysaccharide vaccine

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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280 participants in 4 patient groups

Neonatal PCV + PPV 9 months

Active Comparator group

Description:

Group 1: Children receiving 7VPCV at 0-1-2 months of age and PPV at 9 months of age

Treatment:

Biological: Prevenar + PPV

Infant PCV + PPV at 9 months

Active Comparator group

Description:

Group 2: Children receiving 7VPCV at 1-2-3 months of age and PPV at 9 months of age

Treatment:

Biological: Infant PCV (Prevenar) + PPV at 9 months

No PCV + PPV at 9 months

Active Comparator group

Description:

Group 3: Children who only received PPV at 9 months of age

Treatment:

Biological: No Prevenar + PPV at 9 months

Control

Active Comparator group

Description:

Group 4: Children who have not received any previous pneumococcal vaccine

Treatment:

Biological: Control