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PCV10 Immunogenicity Study Nepal 2015

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ClinicalTrials.gov Identifier: NCT02385513
Recruitment Status : Completed
First Posted : March 11, 2015
Last Update Posted : January 11, 2018
Sponsor:
Collaborators:
Patan Academy of Health Sciences
University of Otago
Johns Hopkins Bloomberg School of Public Health
Information provided by (Responsible Party):
University of Oxford

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. 6+10 weeks and 9 months OR
  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.

Condition or disease Intervention/treatment Phase
Streptococcus Pneumoniae Biological: 10-valent pneumococcal conjugate vaccine Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 304 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Randomised Controlled Trial Comparing Two-Dose Priming With the 10-Valent Pneumococcal Conjugate Vaccine at 6 and 10 Weeks to 6 and 14 Weeks in Nepali Children
Actual Study Start Date : August 21, 2015
Actual Primary Completion Date : January 20, 2017
Actual Study Completion Date : February 23, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 6 + 10 weeks of age PCV10 priming
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
Other Name: Synflorix

Active Comparator: 6 + 14 weeks of age PCV10 priming
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
Other Name: Synflorix




Primary Outcome Measures :
  1. Non-inferiority (proportion of infants with serotype specific IgG ≥0•35μg/mL against pneumococcal vaccine serotypes) [ Time Frame: 9 months ]
    The proportion of infants with serotype specific IgG ≥0•35μg/mL against pneumococcal vaccine serotypes at 9 months of age.


Secondary Outcome Measures :
  1. Serotype proportions (proportion of infants who have PCV10 serotype-specific IgG ≥0•35μg/mL) [ Time Frame: 9 months ]
    The proportion of infants who have PCV10 serotype-specific IgG ≥0•35μg/mL one month after the second priming dose of PCV10 and one month following the 9 month booster.

  2. Serotype GMCs geometric mean concentrations (GMCs) of PCV10 serotype specific IgG) [ Time Frame: 9 months ]
    The geometric mean concentrations of PCV10 serotype specific IgG one month following the second priming dose of PCV10, at 9 months of age, and one month following the 9 month booster for each of the two study groups.

  3. Carriage (Serotype specific pneumococcal carriage) [ Time Frame: 9 months ]
    Serotype specific pneumococcal carriage at age 6 weeks, 1 month following the second priming dose of PCV10 and at age 10 months.

  4. Adverse events [ Time Frame: 9 months ]
    The proportion of adverse events in each group in the week following the 14 weeks of age visit



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Ages Eligible for Study:   6 Weeks to 8 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02385513


Locations
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United Kingdom
Centre for Clinical Vaccinology and Tropical Medicine (CCVTM)
Oxford, Oxfordshire, United Kingdom, OX3 7LE
Sponsors and Collaborators
University of Oxford
Patan Academy of Health Sciences
University of Otago
Johns Hopkins Bloomberg School of Public Health

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Oxford
ClinicalTrials.gov Identifier: NCT02385513     History of Changes
Other Study ID Numbers: 2015/01
First Posted: March 11, 2015    Key Record Dates
Last Update Posted: January 11, 2018
Last Verified: January 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Oxford:
Immunogenicity
Additional relevant MeSH terms:
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Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Vaccines
Heptavalent Pneumococcal Conjugate Vaccine
Immunologic Factors
Physiological Effects of Drugs