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“headline”: “SOP for Vaccine Trial Conduct Aligned with WHO PQ/Prequalification Guidance”,
“description”: “This SOP describes procedures for conducting vaccine trials in alignment with WHO Prequalification (PQ) guidance. It ensures compliance with WHO standards, ethical practices, and readiness for PQ dossier submission supporting global vaccine procurement.”,
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Standard Operating Procedure for Vaccine Trial Conduct Aligned with WHO PQ/Prequalification Guidance

Purpose

The purpose of this SOP is to define standardized procedures for conducting vaccine clinical trials in alignment with World Health Organization (WHO) Prequalification (PQ) guidance. Compliance with PQ ensures that vaccine data supports global procurement and use by United Nations agencies and Gavi, strengthening public health impact.

Scope

This SOP applies to sponsors, CROs, investigators, QA, and regulatory affairs teams engaged in vaccine trials intended for WHO PQ submission. It covers trial design considerations, operational procedures, data integrity requirements, and dossier preparation.

Responsibilities

• Sponsor: Ensures trial design and execution align with WHO PQ guidance and GCP.
• CRO: Oversees operational compliance with PQ trial requirements.
• Investigator: Conducts vaccine trial activities according to protocol, GCP, and PQ standards.
• QA: Audits vaccine trial processes and ensures PQ-readiness of trial data.
• Regulatory Affairs: Coordinates submissions with WHO PQ program.

Accountability

The Sponsor’s Clinical and Regulatory Heads are accountable for ensuring that vaccine trials are PQ-compliant, and trial data is suitable for PQ dossier submission.

Procedure

1. Trial Design and Protocol Development
1.1 Incorporate WHO PQ requirements into vaccine trial protocols.
1.2 Ensure inclusion of appropriate endpoints (safety, immunogenicity, efficacy).
1.3 Document in Protocol Compliance Log (Annexure-1).

2. Site Preparation and Training
2.1 Select PQ-ready trial sites with vaccine cold chain capacity.
2.2 Conduct training for investigators and staff on PQ standards.
2.3 Document in Training Log (Annexure-2).

3. Vaccine Handling and Cold Chain
3.1 Maintain WHO-recommended cold chain conditions (2–8°C unless specified).
3.2 Record in Vaccine Cold Chain Log (Annexure-3).

4. Data Collection and Integrity
4.1 Collect safety, efficacy, and immunogenicity data per PQ requirements.
4.2 Ensure ALCOA+ principles in data capture.
4.3 Document in Data Integrity Log (Annexure-4).

5. SAE and SUSAR Reporting
5.1 Report safety events per WHO PQ requirements.
5.2 Document in Safety Reporting Log (Annexure-5).

6. PQ Dossier Preparation
6.1 Compile PQ dossier sections covering quality, safety, and efficacy.
6.2 Archive dossier documents in TMF.
6.3 Record in PQ Dossier Preparation Log (Annexure-6).

Abbreviations

• SOP: Standard Operating Procedure
• PQ: Prequalification
• WHO: World Health Organization
• CRO: Contract Research Organization
• QA: Quality Assurance
• SAE: Serious Adverse Event
• SUSAR: Suspected Unexpected Serious Adverse Reaction
• TMF: Trial Master File
• GCP: Good Clinical Practice

Documents

1. Protocol Compliance Log (Annexure-1)
2. Training Log (Annexure-2)
3. Vaccine Cold Chain Log (Annexure-3)
4. Data Integrity Log (Annexure-4)
5. Safety Reporting Log (Annexure-5)
6. PQ Dossier Preparation Log (Annexure-6)

References

• WHO Prequalification of Medicines and Vaccines
• ICH GCP Guidelines
• Gavi – The Vaccine Alliance

Version: 1.0

Approval Section

Annexures

Annexure-1: Protocol Compliance Log

Annexure-2: Training Log

Annexure-3: Vaccine Cold Chain Log

Annexure-4: Data Integrity Log

Annexure-5: Safety Reporting Log

Annexure-6: PQ Dossier Preparation Log

Revision History

For more SOPs visit: Pharma SOP