Pneumococcal Vaccination of Fiji Infants

NCT00170612 | Completed Phase 2 DMC

• 2 other identifiers: 03-042FNRERC Reference # 2002-001
• Study Type: interventional
• Target: 552
• Locations: 1 country
• Sites: 1

Brief Summary

Pneumonia is the most common reason for admission of Fijian children to hospitals. The most common germ causing pneumonia is "streptococcus pneumoniae." It is a common cause of meningitis (infection around the brain and spinal cord), ear infections, and blood infections and it lives in the nose of humans. A vaccine has been developed that will help prevent these common diseases but prevents only about one quarter of pneumonia cases and it is expensive. This study explores new ways of giving this vaccine that are affordable, safe, and effective in countries such as Fiji. About 550 Fijian infants presenting at 6 weeks of age, for their first diptheria, tetanus, toxoid, pertussis vaccine immunization, to one of the participating Health Centers or Colonial War Memorial Hospital in urban Suva, Fiji will be enrolled. Children will remain in the study for 2 years. Study procedures include full vaccination against 7 types of pneumococcus, blood tests, and nasal swabs.

Conditions

Pneumococcal Infections

Keywords

Pneumococcal infections; Fiji; infants; vaccine

Outcome Measures

Primary Outcomes (1)

• For each serotype assayed (23 for ELISA and 11 for functional assays) the proportion of children responding to the micro-PPS dose at 18 months and the GMC of the response will be compared between children who receive PPS at 12 months and those who do not

  19 months of age

Secondary Outcomes (3)

• Proportion of children showing hyporesponse at 18 months to more than half of all 23 serotypes

  18 weeks; 12.5 months of age

• Immunogenicity and carriage: Immune responses following the primary series of conjugate vaccination, measured by ELISA and OPA will be compared between the group receiving two doses of PCV and those receiving 3 doses of vaccine

  18 months of age

• Rate of decline: assessment of antibody levels

  12 months

Study Arms (8)

A

EXPERIMENTAL

PCV at 6 weeks, 10 weeks, and 14 weeks; PPS at 18 months

Biological: Pneumovax 23; Biological: Prevnar

B

EXPERIMENTAL

PCV at 6 weeks, 10 weeks, and 14 weeks; PPS at 12 months and 18 months

Biological: Pneumovax 23; Biological: Prevnar

C

EXPERIMENTAL

PCV at 6 weeks and 14 weeks; PPS at 18 months

Biological: Pneumovax 23; Biological: Prevnar

D

EXPERIMENTAL

PCV at 6 weeks and 14 weeks; PPS at 12 months and 18 months

Biological: Pneumovax 23; Biological: Prevnar

E

EXPERIMENTAL

PCV at 14 weeks; PPS at 18 months

Biological: Pneumovax 23; Biological: Prevnar

F

EXPERIMENTAL

PCV at 14 weeks; PPS at 12 months and 18 months

Biological: Pneumovax 23; Biological: Prevnar

G

EXPERIMENTAL

No PCV; PPS at 12 months and 18 months

Biological: Pneumovax 23

H

ACTIVE COMPARATOR

No PCV; PPS at 18 months

Biological: Pneumovax 23

Interventions

Pneumovax 23 BIOLOGICAL

23-valent PPS, 25 micrograms/serotype

A; B; C; D; E; F; G; H

Prevnar BIOLOGICAL

7-valent PCV, 2 micrograms/serotype, except serotype 6B which is 4 micrograms/serotype

A; B; C; D; E; F

Eligibility Criteria

• Age: 6 Weeks - 8 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Healthy infant aged between 6 and 8 weeks
• No significant maternal or perinatal history
• Written and signed parental/caregiver consent
• Lives within 30 minutes of the health clinic
• Family anticipate living in the study area for the next 2 years

You may not qualify if:

• Known allergy to any component of the vaccine
• Allergic reaction or anaphylactoid reaction with previous vaccines
• Known immunodeficiency disorder
• HIV positive mother (many women are tested for HIV antenatally, however a test is not planned; therefore it would be based on clinic records or self report)
• Known thrombocytopenia or coagulation disorder
• On immunosuppressive medication
• Received any blood product since birth
• Severe congenital anomaly
• Chronic or progressive disease
• Seizure disorder
• History of invasive Pneumococcal, meningococcal, or Haemophilus influenzae diseases

Sponsors & Collaborators

• University of Melbourne: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (1)

Colonial War Memorial Hospital

Suva, Fiji

Location

Related Publications (5)

• Russell FM, Balloch A, Licciardi PV, Carapetis JR, Tikoduadua L, Waqatakirewa L, Cheung YB, Mulholland EK, Tang ML. Serotype-specific avidity is achieved following a single dose of the 7-valent pneumococcal conjugate vaccine, and is enhanced by 23-valent pneumococcal polysaccharide booster at 12 months. Vaccine. 2011 Jun 15;29(27):4499-506. doi: 10.1016/j.vaccine.2011.04.038. Epub 2011 May 1.

  PMID: 21539882 DERIVED

• Russell FM, Carapetis JR, Burton RL, Lin J, Licciardi PV, Balloch A, Tikoduadua L, Waqatakirewa L, Cheung YB, Tang ML, Nahm MH, Mulholland EK. Opsonophagocytic activity following a reduced dose 7-valent pneumococcal conjugate vaccine infant primary series and 23-valent pneumococcal polysaccharide vaccine at 12 months of age. Vaccine. 2011 Jan 10;29(3):535-44. doi: 10.1016/j.vaccine.2010.10.046. Epub 2010 Oct 31.

  PMID: 21044669 DERIVED

• Russell FM, Carapetis JR, Satzke C, Tikoduadua L, Waqatakirewa L, Chandra R, Seduadua A, Oftadeh S, Cheung YB, Gilbert GL, Mulholland EK. Pneumococcal nasopharyngeal carriage following reduced doses of a 7-valent pneumococcal conjugate vaccine and a 23-valent pneumococcal polysaccharide vaccine booster. Clin Vaccine Immunol. 2010 Dec;17(12):1970-6. doi: 10.1128/CVI.00117-10. Epub 2010 Oct 13.

  PMID: 20943882 DERIVED

• Russell FM, Carapetis JR, Balloch A, Licciardi PV, Jenney AW, Tikoduadua L, Waqatakirewa L, Pryor J, Nelson J, Byrnes GB, Cheung YB, Tang ML, Mulholland EK. Hyporesponsiveness to re-challenge dose following pneumococcal polysaccharide vaccine at 12 months of age, a randomized controlled trial. Vaccine. 2010 Apr 26;28(19):3341-9. doi: 10.1016/j.vaccine.2010.02.087. Epub 2010 Mar 4.

  PMID: 20206670 DERIVED

• Russell FM, Licciardi PV, Balloch A, Biaukula V, Tikoduadua L, Carapetis JR, Nelson J, Jenney AW, Waqatakirewa L, Colquhoun S, Cheung YB, Tang ML, Mulholland EK. Safety and immunogenicity of the 23-valent pneumococcal polysaccharide vaccine at 12 months of age, following one, two, or three doses of the 7-valent pneumococcal conjugate vaccine in infancy. Vaccine. 2010 Apr 19;28(18):3086-94. doi: 10.1016/j.vaccine.2010.02.065. Epub 2010 Mar 1.

  PMID: 20199764 DERIVED

MeSH Terms

Conditions

Pneumococcal Infections

Interventions

23-valent pneumococcal capsular polysaccharide vaccine; Heptavalent Pneumococcal Conjugate Vaccine

Condition Hierarchy (Ancestors)

Streptococcal Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Pneumococcal Vaccines; Streptococcal Vaccines; Bacterial Vaccines; Vaccines; Biological Products; Complex Mixtures; Vaccines, Combined

Study Officials

• Fiona M Russell, FRACP

  University of Melbourne

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 15, 2005
• Study Start: November 1, 2005
• Primary Completion: January 1, 2008
• Study Completion: August 1, 2008
• Last Updated: October 21, 2008

Record last verified: 2008-10

Locations

FI (1)