Hexavalent vaccines

GSK

Sanofi Pasteur

MCM Vaccine B.V. (MSD/Sanofi partnership)

Serum Institute of India

DT3aP-HepB-Hib-IPV

DT2aP-HepB-Hib-IPV

DT5aP-HepB-Hib-IPV

DTwP-HepB-Hib-IPV

EMA

FDA

EMA

India

2000

2012

2016

2022

N/A

2012

2018

N/A

2000

2013

2016

N/A

N/A

2014

N/A

2024

No

No

No

No

Aluminum hydroxide, hydrated (0.50 mg Al3+)

Aluminum phosphate (0.32 mg Al3+)

Aluminum hydroxide, hydrated (0.60 mg Al3+)

Amorphous aluminum hydroxyphosphate sulfate (0.15 mg Al3+)

Aluminum phosphate (0.17 mg Al3+)

Aluminum phosphate (<1.25 mg Al3+)

None

None

None

2-phenoxyethanol

Yes

Not required

Not required

Not required

Powder (Hib) and suspension for suspension for injection

Fully liquid

Fully liquid

Fully liquid

Poweder in vial (Type-1) + 0.5ml in 1ml Type 1 pre-filled syringe

0.5 mL in 1 mL Type 1 pre-filled syringe
Single dose glass vial (PQ)

0.5 mL in pre-filled syringe (type I glass)

10 doses vial

Intramuscular

Intramuscular

Intramuscular

Intramuscular

48 months

36 months

48 months

24 months

2-8°C

2-8°C

2-8°C

2-8°C

N/A

Type 7

N/A

Type 11

N/A

11.32 for vial presentation

N/A

2.11

Two or three doses (of 0.5 ml) which should be administered according to official recommendations. The Expanded Program on Immunisation schedule (at 6, 10, 14 weeks of age) may only be used if a dose of hepatitis B vaccine has been given at birth.

Two doses (with an interval of at least 8 weeks) or three doses (with an interval of at least 4 weeks) in accordance with the official recommendations. All vaccination schedules including the WHO Expanded Program on Immunisation (EPI) at 6, 10, 14 weeks of age can be used whether or not a dose of hepatitis B vaccine has been given at birth.

Two or three doses, with an interval of at least 1 month between doses, and may be given from 6 weeks of age, in accordance with the official
recommendations. Where a dose of hepatitis B vaccine is given at birth, Vaxelis can be used for supplementary doses of
hepatitis B vaccine from the age of 6 weeks

Three doses of 0.5 ml to be administered with an interval of at least four weeks between doses starting at six weeks of age.
In countries, where peri-natal transmission of hepatitis B virus (HBV) is common, the first dose of Hepatitis B should be given as soon as possible after birth. In this case, the HEXASIIL® can be used to complete the primary series from 6 weeks of age.

N/A

N/A

N/A

N/A

After a 2-dose or a 3-dose primary series vaccination with Infanrix hexa, a booster dose with Infanrix hexa should be given at least 6 months after the last priming dose

After a 2-dose primary vaccination with Hexacima, a booster dose must be given. After a 3-dose primary vaccination with Hexacima, a booster dose should be given.
Booster doses should be given at least 6 months after the last priming dose and in accordance with the official recommendations.

After a 2-dose or a 3-dose primary series vaccination with Vaxelis, a booster dose should be given at least 6 months after the last priming dose.

A booster dose of DTP, Hib and IPV should be given preferably during the second year of life (≥ 6 months after last primary dose). Booster doses should be given in accordance with the official recommendations. Booster dose may be provided to children having received primary vaccination of HEXASIIL® or any other DTP containing vaccine and Poliomyelitis Vaccine (OPV and/or IPV).

The safety and efficacy of Infanrix hexa in children over 36 months of age have not been established.

The safety and efficacy of Hexacima in infants less than 6 weeks of age have not been established. No data are available in older children

The safety and efficacy of Vaxelis in infants less than 6 weeks of age have not been established. No data are available in older children

0

NO

NO

NO

YES

Detailed pricing information for UNICEF and PAHO procurement can be found at: https://www.unicef.org/supply/documents/dtwp-hepb-ipv-hib-hexavalent-va… and https://www.paho.org/en/documents/revolving-fund-vaccine-prices-2025

Detailed pricing information for UNICEF and PAHO procurement can be found at: https://www.unicef.org/supply/documents/dtwp-hepb-ipv-hib-hexavalent-va… and https://www.paho.org/en/documents/revolving-fund-vaccine-prices-2025

Detailed pricing information for UNICEF and PAHO procurement can be found at: https://www.unicef.org/supply/documents/dtwp-hepb-ipv-hib-hexavalent-va… and https://www.paho.org/en/documents/revolving-fund-vaccine-prices-2025

Detailed pricing information for UNICEF and PAHO procurement can be found at: https://www.unicef.org/supply/documents/dtwp-hepb-ipv-hib-hexavalent-va… and https://www.paho.org/en/documents/revolving-fund-vaccine-prices-2025

1. Knuf, M., Haas, H., García-Corbeira, P., Turriani, E., Mukherjee, P., Janssens, W., & Berlaimont, V. (2021). Hexavalent vaccines: What can we learn from head-to-head studies? Vaccine, 39(41), 6025–6036. https://doi.org/10.1016/j.vaccine.2021.08.086
2. European Medicines Agency (EMA) (no date). Infanrix Hexa: EPAR – Product Information. Available at: https://www.ema.europa.eu/en/documents/product-information/infanrix-hex… [accessed 30 June 2025].

1. Knuf, M., Haas, H., García-Corbeira, P., Turriani, E., Mukherjee, P., Janssens, W., & Berlaimont, V. (2021). Hexavalent vaccines: What can we learn from head-to-head studies? Vaccine, 39(41), 6025–6036. https://doi.org/10.1016/j.vaccine.2021.08.086
2. World Health Organization (WHO) (no date). List of Prequalified Vaccines. Available at: https://extranet.who.int/prequal/vaccines/list-prequalified-vaccines [accessed 30 June 2025].
3. European Medicines Agency (EMA) (no date). Hexacima: EPAR – Product Information. Available at: https://www.ema.europa.eu/en/documents/product-information/hexacima-epa… [accessed 30 June 2025].

1. Knuf, M., Haas, H., García-Corbeira, P., Turriani, E., Mukherjee, P., Janssens, W., & Berlaimont, V. (2021). Hexavalent vaccines: What can we learn from head-to-head studies? Vaccine, 39(41), 6025–6036. https://doi.org/10.1016/j.vaccine.2021.08.086
2. European Medicines Agency (EMA) (no date). Vaxelis: EPAR – Product Information. Available at: https://www.ema.europa.eu/en/documents/product-information/vaxelis-epar… [accessed 30 June 2025].
3. Vaxelis (no date). VAXELIS Dosing, Administration and Storage Transition Tool. Available at: https://www.vaxelis.com/wp-content/uploads/sites/123/2025/02/VAXELIS-Do… [accessed 30 June 2025].

1. World Health Organization (WHO) (no date). HexaSIIL vaccine prequalification details. Available at: https://extranet.who.int/prequal/vaccines/p/hexasiil-0 [accessed 30 June 2025].
2. World Health Organization (WHO) (no date). List of prequalified vaccines. Available at: https://extranet.who.int/prequal/vaccines/list-prequalified-vaccines [accessed 30 June 2025].
3. World Health Organization (WHO) (no date). HexaSIIL product information – UNICEF tender. Available at: https://extranet.who.int/prequal/sites/default/files/vwa_vaccine/FVP-P-… [accessed 30 June 2025].