Assess the Safety and Immunogenicity of PNEUMOSIL® Vaccine in Healthy Vietnamese Children, 6 Weeks to 24 Months of Age

NCT05140720 | Unknown

• 1 other identifier: VX.2020.07
• Study Type: interventional
• Target: 300
• Locations: 0 countries
• Sites: N/A

Brief Summary

The current study provides data necessary to evaluate the safety and immunogenicity of Serum Institute of India's PNEUMOSIL® \[Pneumococcal Polysaccharide Conjugate Vaccine Adsorbed (10-Valent)\] in Healthy Vietnamese Infants and Toddlers, 6 weeks to 24 months of age. This is an open label, prospective, bridging study.

Conditions

Streptococcus Pneumonia; Vaccine Preventable Disease

Keywords

pneumonia; Pneumococcal vaccine; Vaccine; healthy infants and toddlers

Outcome Measures

Primary Outcomes (5)

• Percent of participants with immediate solicited adverse events (AEs), serious adverse events (SAEs) at least 30 minutes after each study vaccine administration.

  The incidence and severity of immediate solicited local and systemic AEs, SAEs at least 30 minutes observation after each dose of the study vaccine.

  30 minutes after each vaccination

• Percent of participants with solicited AEs, SAEs within 7 days after each study vaccine administration.

  The incidence and severity of solicited local and systemic AEs, SAEs within 7 days after each dose of the study vaccine.

  within 7 days after each vaccination

• Percent of participants with solicited AEs, SAEs within 28 days after each dose of the study vaccine.

  The incidence and severity of solicited local and systemic AEs, SAEs within 28 days after each dose of the study vaccine

  within 28 days after each vaccination

• Percent of participants with immediate unsolicited AEs, SAEs at least 30 minutes after each study vaccine administration.

  The incidence and severity of immediate unsolicited local and systemic AEs, SAEs at least 30 minutes observation after each dose of the study vaccine.

  30 minutes after each vaccination

• Percent of participants with unsolicited AEs, SAEs until 28 days after the last primary dose.

  Percent of participants with unsolicited local and systemic AEs, SAEs from the first primary dose to 28 days after the last primary dose vaccination.

  From the first primary dose to 28 days after the last primary dose vaccination.

Secondary Outcomes (2)

• Geometric mean (μg/mL) of IgG concentration for each serotype at 28 days after the last primary dose.

  at 28 days after the last primary dose.

• Proportion of patients achieving seroconversion with IgG > 0.35 μg/mL as defined by WHO at 28 days after the last primary dose.

  at 28 days after the last primary dose.

Study Arms (3)

6 weeks - 6 months of age

EXPERIMENTAL

Group 1: Age group from 6 weeks - 6 months

Biological: PNEUMOSIL®

7 - 11 months of age

EXPERIMENTAL

Group 2: Age group from 7 - 11 months

Biological: PNEUMOSIL®

12 - 24 months of age

EXPERIMENTAL

Group 3: Age group from 12 - 24 months

Biological: PNEUMOSIL®

Interventions

PNEUMOSIL® BIOLOGICAL

Study subjects will be vaccinated PNEUMOSIL® with the primary doses as described below: Group 1: 3 doses, 4 to 8 week interval Group 2: 2 doses, dose interval \> 1 month Group 3: 2 doses, dose interval \> 2 months

12 - 24 months of age; 6 weeks - 6 months of age; 7 - 11 months of age

Eligibility Criteria

• Age: 6 Weeks - 24 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Healthy infants or toddlers, based on medical history and clinical assessment, to be without acute or chronic, clinically significant pulmonary, cardiovascular, hepatobiliary, gastrointestinal, renal, neurological, or hematological functional abnormality or illness that requires medical therapy.
• Infants or toddlers between 6 weeks to 24 months of age at the first dose
• Voluntary written informed consent by subject's parents to have the subject participate in the study.
• Subject's parents being able to comprehend and comply with study requirements and procedures and able and willing to complete subject diary, to return with the subject for all scheduled follow-up visits
• Subjects born full-term with a weight-to-length Z score of ≥ -2 (WHO child growth standard) at enrollment.
• Subject with an up-to-date minimal vaccination status for age at the time of enrollment as per National Immunization Program.
• Subject's parents having a readily identifiable place of residence in the study area, being available for the duration of trial participation, with means of telephone contact.

You may not qualify if:

• Use of any investigational medicinal product prior to randomization or planned use of such a product (other than study vaccine) during the period of study participation. Previous vaccination against Streptococcus pneumoniae.
• History of Streptococcus 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. This included such reactions in older siblings and also includes all components of the vaccines of expanded program on immunization.
• History of anaphylactic shock.
• Any abnormal (Grade ≥ 1) vital sign. Note: For fever, axillary temperature of ≥ 37.5°C was considered significant and was repeated to determine whether a subject is eligible for randomization. A minimum of 48 hours following resolution of documented fever needed to pass before the subject could be reassessed for eligibility. The last vital sign measurement was used as the baseline value for the study.
• Any moderate or severe (Grade ≥ 2) acute illness Note: Infants with a Grade 1 acute illness were enrolled at the discretion of the Principal Investigator (PI).
• Note: Subjects with moderate or severe acute illness would return for clinical reassessment; if the illness had sufficiently resolved, they might still qualify for randomization.
• Chronic administration (defined as more than 14 consecutive days) of immunosuppressant or other immune modifying drugs prior to the administration of the study vaccine, including the use of glucocorticoids. The use of topical and inhaled glucocorticoids will be permitted.
• History of administration of a non-study pneumococcal vaccine prior to administration of study vaccine or during the course of study participation (other vaccinations of expanded program on Immunization are accepted).
• Administration of immunoglobulins and/or any blood products or anticipation of such administration during the study period.
• Subject had a sibling die of likely sudden infant death syndrome or 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.
• History of meningitis, seizures or any neurological disorder.
• Evidence by history taking alone of exposure to an HIV-positive individual through maternal fetal transmission, breast milk, or other blood-borne mechanisms.
• Subject being a direct descendant (child or grandchild) of any person employed by the Sponsor, the contract research organization (CRO), the PI, study site personnel, or department.

Sponsors & Collaborators

• Vabiotech: lead
• Vietstar Biomedical Research: collaborator

MeSH Terms

Conditions

Pneumonia; Vaccine-Preventable Diseases

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Son T Vu, PhD

  Vietnam Military Medicine University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Son T Vu, PhD

CONTACT

+84988350535; vutungson1983@vmmu.edu.vn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This will be an open label, prospective, bridging study. Pneumococcal conjugate vaccine (PCV)-native subjects in three pre-defined age groups will be recruited into the study. Age group 1: From 6 weeks - 6 months Age group 2: From 7 months - 11 months Age group 3: From 12 months - 24 months Study subjects will be vaccinated with the primary doses. The dose of 0.5 ml of study vaccine has been selected based on the results from previous clinical studies and in compliance with the approval for marketing authorization in India.

Study Record Dates

• First Submitted: September 26, 2021
• First Posted: December 1, 2021
• Study Start: January 25, 2022
• Primary Completion: February 28, 2022
• Study Completion: June 1, 2022
• Last Updated: December 1, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share