Delivering Excellence in a Large-Scale Late-Phase Vaccine Trial

Articles

Case Study: Flu Vaccine Clinical Trial

STUDY SPONSOR | Large Pharmaceutical

At Optimal Clinical Trials, we believe in the power of research to transform lives and make a positive impact.  That’s why when one of the world’s leading pharmaceutical companies needed to conduct a multi-site, large-scale late phase flu vaccine trial in New Zealand, Optimal rose to the challenge and delivered with the top performance.

Originally designed to include participants aged 18 and older, the protocol was revised at the last minute to target only those aged 65 and older - a group critical for studying vaccine efficacy against severe flu cases. Time was of the essence, as ensuring the vaccine’s availability before flu season was vital to protecting vulnerable populations. Thanks to Optimal’s unwavering dedication and ability to adapt, we not only met what’s required, but exceeded all expectations.

The Challenge


Our team had worked tirelessly to recruit participants aged 18 and over, aligned with the original protocol. The last-minute shift to focus exclusively on participants aged 65 and older required a significant pivot in strategy. This change, combined with the wait for the investigational product, the need for same-day data entry and the long operational days required, created a uniquely demanding environment. Yet, our team embraced the challenge with determination and care.

Our Approach


1. Recruitment Excellence

We tapped into our extensive volunteer database and reached out deeply within our communities to find the right participants. With a dedicated Marketing team leveraging a multi-channel approach that included digital campaigns, traditional marketing, and grassroots outreach, we ensured diversity and quality in our participant pool. Our in-house patient engagement team and investigating doctors meticulously pre-screened candidates to meet the revised protocol requirements.

2. Operational Preparedness

Anticipating the unexpected is part of who we are. Our teams conducted rigorous practice simulations to ensure flawless execution on the day and prepared our response for various scenarios. With clear communication and a shared goal, everyone across all departments was ready to move fast as soon as the investigational product arrived, and the green light was given.

3. Participant Engagement

We focused on making the participant experience as pleasant as possible. Clear directions to our site, free parking, arranged transport for those in need, and complimentary refreshments ensured that every participant felt welcome and valued. We understand that a positive experience fosters trust and retention. Our study coordinators maintained personalised and clear communication with every participant, building trust and ensuring their commitment throughout the trial. This dedication led to an unmatched 100% retention rate - every participant returned for their follow-up appointments and completed the trial, a testament to the care and connection we provided.

Results That Speak for Themselves


Large-Scale Late-Phase Flu Vaccine Trial:

  • Randomised: 531 participants (142% of our target)
  • Central Site: 374 participants, 1st highest site in ANZ
  • North Site: 170 participants, 2nd highest site in ANZ
  • Retention Rate: 100%
  • Total Impact: 46% of all NZ participants for the study were recruited by Optimal

Key Success Factors


This study reflects Optimal’s commitment to performance and care. When lives depend on timely, high-quality research, we deliver to help pharmaceutical and biotech companies achieve breakthroughs that change lives.

  • Flexibility and Agility: Our ability to pivot rapidly in response to protocol changes, provide rapid start up and high-quality recruitment, ensured we delivered above and beyond the sponsor’s expectations.
  • Participant-Centred Care: From our robust database and marketing strategies, phone screening, first visits to follow-up, we prioritised every participant’s comfort and experience, fostering trust and commitment.
  • Uncompromised Quality: Our tried and tested systems and procedure ensured high quality data, backed by our ISO 9001 certification and a recent successful FDA inspection. 
  • Unparalleled Performance: By surpassing all other NZ sites in recruitment and execution, we proved why Optimal is a leader in late-phase vaccine trials.

Our Vaccine Clinical Trial Performance: A Proven Track Record


Optimal Clinical Trials has consistently delivered exceptional results in large-scale late-phase vaccine trials, setting benchmarks for recruitment, retention, and quality:

  • COVID/Flu Combo Vaccine Trial for aged 65 or over (Dec 2024): First patient in NZ 9 Dec 2024 by Optimal; highest recruiting site in ANZ
  • COVID Vaccine Trial for Over 50s (Jan 2023): First patient in NZ 6 Jan 2023 by Optimal; highest recruiting site in NZ
  • Phase 3 Vaccine Trial (May–Jun 2022): Enrolled 201 participants with 97.5% retention; highest recruiter in ANZ
  • COVID-Flu Vaccine Trial (Apr 2022): First patient in NZ 27 Apr 2022 by Optimal; highest recruiter across ANZ; successful FDA inspection
  • Phase 3 Vaccine Trial (Feb–Jun 2022): Enrolled over 220 participants with 100% retention; highest recruiter in ANZ
  • RSV Older Adult Vaccine Trial (Jan 2022): First patient in NZ 28 Jan 2022 by Optimal; highest recruiter across ANZ
  • Phase 3 Vaccine Trial (Dec 2021–Jan 2022): Enrolled 66 participants with 98% retention; highest recruiter in ANZ
  • Maternal Vaccine Trial (Dec 2021): Outperformed other countries; highest recruiter across ANZ
  • Phase 3 Vaccine Trial (May–Jun 2021): Enrolled 75 participants with 97% retention; highest recruiter in ANZ
  • Phase 2 Vaccine Trial (Apr–May 2021): Enrolled 54 participants with 100% retention; highest recruiter in ANZ
  • Phase 3 Maternal RSV Vaccine Trial (Jan 2021–Jan 2022): Enrolled 190 participants; highest recruiter in ANZ
  • Phase 3 Maternal RSV Vaccine Trial (2017–2018): Enrolled 69 participants


Let's rise to the challenge, together

At Optimal Clinical Trials, we understand that clinical research is more than just data points and statistics; it’s about people. That's why we're committed to delivering exceptional research experiences that are both compassionate and effective.

Let’s inspire hope, aid discoveries, and contribute to knowledge that improve lives. Connect with us today to see how we can help you achieve your goals.