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The immunogenicity and safety of the 10-valent pneumococcal nontypeable Haemophilus influenzae (H. Influenzae) protein D conjugate vaccine (PHiD-CV), co-administered with routine childhood vaccines, were assessed in Taiwanese infants. Methods: In this open study, 230 healthy infants were primed with three doses of PHiD-CV (Synflorix) and diphtheria, tetanus, acellular pertussis, hepatitis B (HBV), inactivated poliomyelitis and Haemophilus influenzae type b (Hib) conjugate vaccine (DTPa-HBV-IPV/Hib vaccine) at 1.5, 3 and 6 months of age and two doses of oral human rotavirus vaccine at 1.5 and 3 months. Pneumococcal immune responses were assessed 1 month post-dose three, by 22F-inhibition ELISA and opsonophagocytic activity (OPA) assay. Local and general solicited/unsolicited symptoms and serious adverse events (SAEs) were recorded. Results: At least 95.4% of participants had an antibody concentration ≥0.2 μg/mL against each vaccine serotype. At least 96.1% of participants had an OPA titer ≥8 against each vaccine serotype except 6B (87.3%). All infants, but one, were seropositive for antibodies against nontypeable H. influenzae protein D. Immune responses to the co-administered vaccines were good and in line with previous reports. PHiD-CV was well tolerated, with low (≤6.3%) incidences of grade 3 solicited local symptoms. The frequencies of general symptoms were in line with other pneumococcal conjugate vaccine studies. There were no systematic increases in incidences of solicited general or local symptoms with successive doses. There were no reports of grade 3 fever (rectal temperature > 40 °C) or SAEs considered to be causally related to vaccination. Conclusion: PHiD-CV co-administered with routine childhood vaccines within the first 6 months of life, was highly immunogenic, and well tolerated in Taiwanese infants.

A multicenter study (NCT00449670) conducted across Taiwan, Singapore, Hong Kong and Thailand evaluated the safety and manufacturing consistency of four formulations of an AS03A-adjuvanted H5N1 vaccine in terms of immune response against the vaccine-homologous strain (A/Vietnam/1194/2004). This manuscript presents data from the Taiwanese population. Methods: A total of 400 individuals, aged 18–60 years, were randomized into six groups (2:2:2:2:1:1 ratio) to receive two doses (21 days apart) of one of the four adjuvanted formulations (H5N1-AS03A-groups) or one of the two nonadjuvanted formulations (H5N1-DIL-groups). Blood samples collected before vaccination (Day 0) and 21 days after each vaccine dose were analyzed using hemagglutination inhibition (HI) assay. Adverse events were recorded. Results: All four AS03A-adjuvanted formulations induced comparable immune responses against the A/Vietnam/1194/2004 strain; following the second dose, immune response in terms of HI antibodies was higher in the H5N1-AS03A-groups {seroprotection rate=91.6% [95% confidence interval (CI): 87.9–94.4]; geometric mean titer (GMT)=177.6 (95% CI: 153.2–206.0)} compared with the H5N1-DIL-groups [seroprotection rates=5.0% (95% CI: 1.4–12.3); GMT=6.3 (95% CI: 5.4–7.4)]. Immune response against the heterologous A/Indonesia/05/2005 strain was also stronger in the H5N1-AS03A-groups [seroprotection rate=45.6% (95% CI: 40.0–51.4); GMT=20.5 (95% CI: 17.8–23.7)] compared with the H5N1-DIL groups [seroprotection rate=0.0% (95% CI: 0.0–4.5); GMT=5.0 (95% CI: 5.0–5.0)]. The overall reactogenicity profile of the adjuvanted formulations was clinically acceptable. Conclusion: The AS03A-adjuvanted H5N1 influenza vaccine formulations induced stronger immune response against the vaccine-homologous and heterologous strains than the nonadjuvanted formulations. The AS03A-adjuvanted H5N1 vaccine demonstrated a good immunogenicity and an acceptable safety profile in the Taiwanese population.

Meningococcal disease, including meningitis and sepsis, usually follows an invasive infection by Neisseria meningitidis, and is a major cause of death and morbidity worldwide. Currently available meningococcal vaccines that consist of pure capsular polysaccharides (serogroups A, C, W-135 and Y) are generally safe and efficacious in adults and children aged >2 years. The purpose of this study was to evaluate the immunogenicity, safety and reactogenicity of a single dose of GlaxoSmithKline Biologicals' Mencevax™ ACWY vaccine in healthy Taiwanese subjects aged 2–30 years. Methods: This open, single center, Phase III study was conducted in Taiwan. A single dose of the Mencevax™ ACWY vaccine was administered to subjects aged 2–30 years. Immunogenicity and safety of the vaccine were evaluated after vaccination. Results: The immunogenicity results obtained 1 month after vaccination with Mencevax™ ACWY vaccine indicated that the vaccine elicited a good immune response in vaccinees aged 2–30 years. This was both in terms of functional activity directed against meningococcal polysaccharide (A, C, W-135 and Y) as measured by serum bactericidal assay (>93% activity against all serogroups), and specific IgG concentrations measured by ELISA (>96% seropositivity to all serogroups). Conclusion: The tetravalent polysaccharide Mencevax™ ACWY meningococcal vaccine was well tolerated and immunogenic in subjects aged 2–30 years in Taiwan.

Immunogenicity and reactogenicity of the combined diphtheria-tetanus-acellular pertussis-inactivated poliovirus-Haemophilus influenzae type b (Hib) conjugate vaccine (DTPa-IPV/Hib, Infanrix™-IPV + Hib) was assessed when co-administered with hepatitis B (HBV) vaccine. Seventy healthy infants received DTPa-IPV/Hib at 1.5, 3.5, 6 and 15–18 months, and HBV at birth, 1.5, 6 and 15–18 months of age. Serological responses were assessed. Diphtheria, tetanus, Hib and pertussis seroprotection/seropositivity rates were 100% after primary vaccination. Post-primary immune responses to poliovirus could not be evaluated for technical reasons. However, after the booster dose, seroprotection/seropositivity rates, including poliovirus, were 100%. Over 95% were seroprotected against HBV. Post-booster geometric mean antibody concentrations/titers (GMC/GMTs) rose from 14-fold to 45-fold, indicating effective priming against all antigens, including polioviruses. DTPa-IPV/Hib was well tolerated alone or co-administered with HBV. No serious adverse events were considered related to vaccination. Primary and booster vaccination with combined DTPa-IPV/Hib and HBV was immunogenic and well tolerated. Combination vaccines enable vaccine providers to conveniently provide routine pediatric immunizations, with minimal discomfort.

Immunogenicity and reactogenicity of primary vaccination with combined diphtheria–tetanus–acellular pertussis–hepatitis B–inactivated poliovirus (DTPa–HBV–IPV) vaccine when co-administered with Haemophilus influenzae (Hib) conjugate vaccine were assessed in 60 healthy infants. Infants received HBV vaccine at birth, then DTPa–HBV–IPV and Hib vaccines at age 1.5 months, 3.5 months and 6 months. Blood samples were collected before the first DTPa–HBV–IPV and Hib vaccine doses and 1 month after dose 3. Reactogenicity was assessed using diary cards. One month after primary vaccination, all infants were seroprotected/seropositive against all vaccine antigens evaluated. The poliovirus antigen could not be evaluated. The vaccines were well tolerated. No case of fever > 39.0°C was reported. No serious adverse events were considered related to vaccination. Primary vaccination with DTPa–HBV–IPV and Hib vaccines was immunogenic and well tolerated. Combined vaccines, such as this pentavalent vaccine, minimize the number of injections and vaccination visits required to complete primary vaccination, and provide choice and flexibility for physicians and vaccine providers.