Pneumococcal Vaccines Early and in Combination

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01174849
• Date of registration: 02/08/2010
• Prospective Registration: Yes
• Primary sponsor: Menzies School of Health Research
• Public title: Pneumococcal Vaccines Early and in Combination PREVIX_COMBO
• Scientific title: A Randomised Controlled Trial of Pneumococcal Conjugate Vaccines Synflorix and Prevenar13 in Sequence or Alone in High-risk Indigenous Infants (PREV-IX_COMBO): Immunogenicity, Carriage and Otitis Media Outcomes
• Date of first enrolment: August 2011
• Target sample size: 425
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01174849
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: None (Open Label).
• Phase: Phase 4

Countries of recruitment

Australia

Contacts

• Name: Amanda J Leach, PhD
• Affiliation: Menzies School of Health Research

Key inclusion & exclusion criteria

Inclusion Criteria:

Indigenous infants

- 4 to 6 weeks of age

- Living in remote communities that have provided signed Expressions of Interest in
participating in PREV-IX_COMBO trial

- Intend to remain in their community until their baby is 7 months of age

- Eligible for routine vaccinations.

Exclusion Criteria:

- Prior adverse reaction to pneumococcal conjugate vaccines according to Australian
Immunization Handbook.

- Gestational age < 32 weeks



Age minimum: N/A
Age maximum: 38 Days
Gender: All

Health Condition(s) or Problem(s) studied

Otitis Media

Intervention(s)

Drug: Prevenar13

Drug: Synflorix

Drug: COMBO

Primary Outcome(s)

Immunogenicity [Time Frame: 7 months of age]

Secondary Outcome(s)

nasopharyngeal carriage [Time Frame: 7 months of age]

otitis media [Time Frame: 7 months of age]

Secondary ID(s)

605810

ACTRN12610000544077

Source(s) of Monetary Support

Please refer to primary and secondary sponsors