PCV10 Immunogenicity Study Nepal 2015

NCT02385513 | Completed Phase 4 DMC

• 1 other identifier: 2015/01
• Study Type: interventional
• Target: 304
• Locations: 1 country
• Sites: 1

Brief Summary

A single centre open-label, parallel group, randomised controlled trial, recruiting healthy Nepalese infants aged 40-60 days, who present to the immunisation clinic at Patan Hospital, Kathmandu, Nepal, randomised to receive a 10-valent pneumococcal conjugate vaccine (PCV10) at either;

1. 1.6+10 weeks and 9 months OR
2. 2.6+14 weeks and 9 months The study will enroll 152 healthy Nepalese infants in each treatment arm (304 in total). Demographic and clinical data will be collected on an electronic case report form to allow monitoring remotely. Participants will receive the study vaccine according to their allocated treatment arm in addition to their other routine vaccines. The investigators will collect 3 blood samples for analysis of serum antibody responses to the PCV10 vaccine serotypes throughout infancy (see Table 1). The data collected will be analysed in order to determine whether the 6+10 schedule is non-inferior to the 6+14 schedule in generating immune responses against the vaccine serotypes above the ≥0•35μg/mL threshold. These data will then be used to inform decision-making around augmenting the currently recommended 6+14 schedule to a 6+10 schedule in Nepal. The investigators will collect a nasopharyngeal swab at 2 time points to look at carriage of pneumococcus over time and to assess differences between the 2 groups. This is of critical importance because much of the programmatic impact of PCV is ultimately conferred by reductions in carriage at the community level and indirect effects resulting from that nasopharyngeal (NP) protection.

Conditions

Streptococcus Pneumoniae

Keywords

Immunogenicity

Outcome Measures

Primary Outcomes (1)

• Non-inferiority (proportion of infants with serotype specific IgG ≥0•35μg/mL against pneumococcal vaccine serotypes)

  The proportion of infants with serotype specific IgG ≥0•35μg/mL against pneumococcal vaccine serotypes at 9 months of age.

  9 months

Secondary Outcomes (4)

• Serotype proportions (proportion of infants who have PCV10 serotype-specific IgG ≥0•35μg/mL)

  9 months

• Serotype GMCs geometric mean concentrations (GMCs) of PCV10 serotype specific IgG)

  9 months

• Carriage (Serotype specific pneumococcal carriage)

  9 months

• Adverse events

  9 months

Study Arms (2)

6 + 10 weeks of age PCV10 priming

ACTIVE COMPARATOR

10 valent pneumococcal conjugate vaccine administered (PCV10) at 6 and 10 weeks of age with a booster at9 months of age and routine vaccines administered as per the Nepal EPI schedule

Biological: 10-valent pneumococcal conjugate vaccine

6 + 14 weeks of age PCV10 priming

ACTIVE COMPARATOR

10 valent pneumococcal conjugate vaccine administered (PCV10) at 6 and 14 weeks of age with a booster at 9 months of age and routine vaccines administered as per the Nepal EPI schedule

Biological: 10-valent pneumococcal conjugate vaccine

Interventions

10-valent pneumococcal conjugate vaccine BIOLOGICAL

Also known as: Synflorix

6 + 10 weeks of age PCV10 priming; 6 + 14 weeks of age PCV10 priming

Eligibility Criteria

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

You may qualify if:

• Male or Female, aged 40-60 days at time of first study vaccination
• Parent/ guardian of participant is willing and able to give informed consent for participation in the study.
• In good general health as determined by:
• medical history
• physical examination
• clinical judgment of the investigator
• Participants residing in Kathmandu
• Parents able (in the Investigators opinion) and willing to comply with all study requirements.

You may not qualify if:

• Parent/guardian unwilling or unable to give written informed consent to participate in the study
• Previous immunisation (excluding BCG, OPV, hepatitis B, measles or other government vaccine programme) or planned vaccination during the study period with vaccine not foreseen by this study protocol except influenza vaccine and oral polio vaccination as recommended locally.
• Premature birth (\<37 weeks gestation)
• Previous hospital admission except where hospital stay would not compromise the study in the judgment of the investigator.
• Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study.
• Use of any investigational or non-registered product (drug or vaccine) within 30 days preceding the vaccination, or planned use during the study period.
• Concurrently participating in another clinical study, at any time during the study period, in which the participant has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).

Sponsors & Collaborators

• University of Oxford: lead
• Patan Academy of Health Sciences: collaborator
• University of Otago: collaborator
• Johns Hopkins Bloomberg School of Public Health: collaborator

Study Sites (1)

Centre for Clinical Vaccinology and Tropical Medicine (CCVTM)

Oxford, Oxfordshire, OX3 7LE, United Kingdom

Location

Related Publications (1)

• Kandasamy R, Gurung M, Thorson S, Yu LM, Galal U, Voysey M, Kelly S, Wahl B, Berbers G, Finnegan K, Ansari I, Paudel K, Murdoch DR, O'Brien KL, Kelly DF, Goldblatt D, Shrestha S, Pollard AJ. Comparison of two schedules of two-dose priming with the ten-valent pneumococcal conjugate vaccine in Nepalese children: an open-label, randomised non-inferiority controlled trial. Lancet Infect Dis. 2019 Feb;19(2):156-164. doi: 10.1016/S1473-3099(18)30568-1. Epub 2019 Jan 8.

  PMID: 30635252 DERIVED

MeSH Terms

Interventions

10-valent pneumococcal conjugate vaccine; PHiD-CV vaccine

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2015
• First Posted: March 11, 2015
• Study Start: August 21, 2015
• Primary Completion: January 20, 2017
• Study Completion: February 23, 2017
• Last Updated: January 11, 2018

Record last verified: 2018-01

Locations

GB (1)