Flu Vaccine Clinical Trial June 2025

Articles

Case Study: Flu Vaccine Clinical Trial June 2025

STUDY SPONSOR | Global Pharmaceutical Company

Older adults vaccine


When a global pharmaceutical sponsor needed rapid, high quality delivery of a large scale late phase flu vaccine trial, Optimal Clinical Trials and New Zealand delivered. Our Central site randomised the first participant in New Zealand within 14 hours of activation and was the #1 recruiting site globally out of 45 centres. While our North team screened their first participant in just 2 hours after site activation.

This proved once again that New Zealand with Optimal is a winning combination and a high-performing, agile partner in global clinical research.

The Challenge

This study brought several logistical and recruitment challenges:

  • Recruitment began months after the Ministry of Health had already provided the free seasonal flu vaccine to New Zealanders aged 65 and over, making anyone who had received it ineligible for the trial
  • Shifting First Patient In (FPI) dates led to attrition risk among eligible participants
  • Recruitment window was limited to just two to three weeks for full screening, enrolment, and randomisation
  • Optimal’s Central site was assigned the highest enrolment target out of all 45 participating sites globally

Our Approach

With deep vaccine trial experience and cross-functional alignment, Optimal’s teams executed at speed with precision. Site operations remained focused on delivering timely, high-quality data without compromising the participant’s experience.

Participant Centred Strategy

  • Our extensive database was used to identify eligible participants in advance and maintain engagement throughout shifting timelines
  • Effective engagement helped manage expectations and minimised dropout
  • When activation delays impacted planned enrolment, we backfilled through community engagement and targeted advertising campaigns

Operational Readiness

  • Our sites were fully staffed and activation ready within hours of green light
  • Advance planning, simulation, and role clarity ensured seamless mobilisation
  • We randomised the first New Zealand participant within 14 hours of site activation, allowing us to start strong and maintain steady enrolment

Study Outcomes

Combined Site Performance

Optimal Central and North sites

  • Total participants enrolled across both sites: 577 in 2.5 weeks
  • Contributed 79% of the country’s overall recruitment

Optimal Central Site

  • First participant randomised in New Zealand within 14 hours of activation
  • #1 recruiting site globally out of 45 participating centres
  • Enrolled 485 participants in 2.5 weeks
  • Achieved 112.8% of site enrolment target
  • Contributed 66% of New Zealand’s total participants

Optimal North Site

  • Second highest enrolling site in New Zealand
  • Enrolled 92 participants in 2.5 weeks
  • Achieved 131.4% of site target
  • Contributed more than 12% of New Zealand’s national total

National Contribution and Global Context

  • New Zealand achieved 112.3 % of its national enrolment target
  • New Zealand enrolled the equivalent of 95 percent of South Africa’s and 86 percent of Australia’s totals
  • For a country of around 5.3 million, with 72 percent of the population open to participating in research, New Zealand continues to demonstrate strong enrolment performance and strategic value for global trials

Key Success Factors

  • Operational Agility: We adapted to changing timelines and without compromising on speed or quality
  • Participant Focus: We prioritise retention, trust, and participant satisfaction through clear communication and coordinated care
  • Proven Systems and Procedure: With ISO 9001 certification, validated processes, and a track record of successful FDA inspection, Optimal delivers data you can rely on
  • Global Benchmark Performance: From first patient in to last patient screened, our New Zealand team set the global benchmark for recruitment and delivery in this study

Ready to accelerate your next trial? At Optimal Clinical Trials, we support sponsors and CROs to deliver high performance trials with fast startup, a participant focused approach, and compliance with the highest international standards.

Let’s set you up for success and show you how our Optimal team can recruit at speed and deliver with confidence.

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