NCT00170612

A Single-Blind Open-Label Randomized Phase II Study of the Safety, Immunogenicity and Impact on Pneumococcus (Pnc) Carriage of the Pnc Vaccination Regimens Combining 1, 2, or 3 Doses of 7-Valent Pneumococcal Conjugate Vaccine (PCV) in the First 4 Months of Life Followed by a Single Dose of 23-Valent Pneumococcal Polysaccharide Vaccine (PPS) at 12 Months of Age

Completed Phase 2 Last updated 20 October 2008

What this trial tests

Phase 2 trial testing Pneumovax 23 in Pneumococcal Infections in 552 participants. Completed in 1 August 2008.

Timeline

1 November 2005

Primary endpoint
1 January 2008

1 August 2008

Quick facts

Lead sponsor	University of Melbourne
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	552
Start date	1 November 2005
Primary completion	1 January 2008
Estimated completion	1 August 2008
Sites	1 location across Fiji

Drugs / interventions tested

• Pneumovax 23 — full drug profile →
• Prevnar — full drug profile →

Conditions studied

• Pneumococcal Infections — all drugs for Pneumococcal Infections →

Sponsor

University of Melbourne

Who can join

Adults 6 Weeks to 8 Weeks, any sex, with Pneumococcal Infections. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• 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
  Time frame: 19 months of age

Sponsor's own description

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.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

1. Hyporesponsiveness to re-challenge dose following pneumococcal polysaccharide vaccine at 12 months of age, a randomized controlled trial.
   Russell FM, Carapetis JR, Balloch A, Licciardi PV, et al · · 2010 · cited 55× · PMID 20206670 · DOI 10.1016/j.vaccine.2010.02.087
2. Pneumococcal nasopharyngeal carriage following reduced doses of a 7-valent pneumococcal conjugate vaccine and a 23-valent pneumococcal polysaccharide vaccine booster.
   Russell FM, Carapetis JR, Satzke C, Tikoduadua L, et al · · 2010 · cited 50× · PMID 20943882 · DOI 10.1128/cvi.00117-10
3. 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.
   Russell FM, Licciardi PV, Balloch A, Biaukula V, et al · · 2010 · cited 26× · PMID 20199764 · DOI 10.1016/j.vaccine.2010.02.065
4. 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.
   Russell FM, Carapetis JR, Burton RL, Lin J, et al · · 2011 · cited 25× · PMID 21044669 · DOI 10.1016/j.vaccine.2010.10.046
5. 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.
   Russell FM, Balloch A, Licciardi PV, Carapetis JR, et al · · 2011 · cited 11× · PMID 21539882 · DOI 10.1016/j.vaccine.2011.04.038