Safety and Immunogenicity of a 10 Valent Pneumococcal Conjugate Vaccine (SIILPCV10) in Healthy Adults, Toddlers, Infants

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02308540
• Date of registration: 24/11/2014
• Prospective Registration: Yes
• Primary sponsor: PATH
• Public title: Safety and Immunogenicity of a 10 Valent Pneumococcal Conjugate Vaccine (SIILPCV10) in Healthy Adults, Toddlers, Infants
• Scientific title: A Phase 1/2, Prospective,Randomized, Active-Controlled, Double-Blind, Age De-escalation Study to Evaluate the Safety, Tolerability, Immunogenicity of Serum Institute of India's PCV10 in Healthy Adults, Toddlers, and Infants
• Date of first enrolment: January 12, 2015
• Target sample size: 346
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02308540
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 1/Phase 2

Countries of recruitment

Gambia

Contacts

• Name: Ed Clarke, MD PhD
• Affiliation: Medical Research Council (MRC) Unit, The Gambia

Key inclusion & exclusion criteria

Inclusion Criteria:

- • Healthy adults (18-40 yrs), toddlers (12-15 mo), full term infants (6-8 wks) and =
3.5 kg

- Able to provide informed consent (for themselves or child)

- Willing to comply with study requirements and procedures.

- Toddlers have completed their Gambian infant EPI schedule

- Infants who have received the birth doses of BCG, HepB and OPV but who have not
received any additional vaccines.

- Infants and toddlers with a weight-to-height Z score of = -2.

- Subjects resident in the study area with no plans to travel outside the study
area during the period of study participation.

Exclusion Criteria:

- Use of any investigational medicinal product within 90 days prior to randomization and
throughout the study.

- Ingestion of herbal or other traditional local medication within 14 days of
randomization.

- Adults and infants who have previously been vaccinated against S. pneumoniae.

- History of S. pneumoniae infection confirmed by culture from a normally sterile site.

- History of allergic disease or history of a serious reaction to any prior vaccination
or known hypersensitivity to any component of the study vaccines.

- History of anaphylactic shock.

- Screening laboratory test or vital signs outside the normal range.

- HIV-positive or HbsAg- positive based on testing during screening.

- Acute illness (moderate or severe) and/or fever (axillary temperature of = 38.0°C for
adults or = 37.5°C for toddlers and infants).

- Use of antibiotics within 5 days of randomization (excluding treatment for malaria).

- A positive test for malaria at time of screening, which remains positive post
treatment when retested at time of randomization (Day 0).

- Administration of any non-study vaccine within 30 days prior to administration of
study vaccine or planned vaccination during the course of study participation.

- Chronic administration of immunosuppressant or other immune modifying drugs prior to
the administration of the study. The use of topical and inhaled glucocorticoids will
be permitted.

- Administration of immunoglobulins and/or any blood products within the 6 months prior
to administration of the study vaccine or during the study period.

- History of known disturbance of coagulation or blood disorder that could cause anemia
or excess bleeding.

- Employee of, or direct descendant of any person employed by the Sponsor, the CRO, the
PI, study site personnel, or site.

Adults only

- Recent history or signs of alcohol or substance abuse.

- History of major psychiatric disorder.

- Female adult subjects who are pregnant or breast-feeding. Infants/Toddlers only

- Family history of suspected primary immunodeficiency in first-degree relative.

- Had a sibling die suddenly and without apparent other cause or preceding illness in
the first year of life.

- Evidence of a clinically significant congenital abnormality as judged by the PI.

- Evidence of fetal alcohol syndrome or maternal history of alcohol abuse during
pregnancy.

- History of meningitis, seizures or any neurological disorder.

- Evidence of exposure to an HIV-positive individual through maternal fetal
transmission, breast milk, or other bloodborne mechanisms



Age minimum: N/A
Age maximum: 40 Years
Gender: All

Health Condition(s) or Problem(s) studied

Pneumococcal Disease

Intervention(s)

Biological: SIILPCV10

Biological: Prevenar 13

Biological: Pneumovax 23

Primary Outcome(s)

Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 3 [Time Frame: 7 days]

Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 2 [Time Frame: 7 days]

Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers [Time Frame: 28 days]

Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity [Time Frame: 7 days]

Occurrence, Severity and Relatedness of All Adverse Events in Infants [Time Frame: 12 weeks post last vaccination]

Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 1 [Time Frame: 7 days]

Occurrence, Severity and Relatedness of Clinically Significant Hematological and Biochemistry Lab Values in Adults and Toddlers [Time Frame: 7 days after vaccination]

Secondary Outcome(s)

Geometric Mean Concentration of Immunoglobulin G (IgG) 4 Weeks After Vaccination for Infants [Time Frame: 4 weeks after the third dose]

Geometric Mean Fold Rise (GMFR) of Immunoglobulin G (IgG) in Toddlers, by Serotype [Time Frame: 4 weeks after vaccination (28 days)]

Geometric Mean Concentration of Immunoglobulin G (IgG) for Adults [Time Frame: 4 weeks after vaccination]

Number and Percentage of Immunoglobulin G (IgG) Seroresponders Against Pentavalent Vaccine Components [Time Frame: 84 days]

Functional Antibody (OPA) Geometric Mean Titers [Time Frame: 4 weeks after last vaccination]

Number and Percentage of Immunoglobulin G (IgG) Seroresponders Among Infants, by Serotype [Time Frame: 4 weeks after third dose]

Geometric Mean Concentration of Immunoglobulin G (IgG) 4 Weeks After Vaccination for Toddlers [Time Frame: 4 weeks after vaccination]

Number and Percentage of Functional (OPA) Infant Seroresponders, by Serotype [Time Frame: 84 days]

Secondary ID(s)

VAC-017

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 02/08/2019
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02308540